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Angio-Seal, StarClose and Vascular Access and Closure Devices (2007 archive)

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This is the archive of questions and comments about vascular closure devices, like AngioSeal, StarClose, VasoSeal, Perclose, Syvek, etc. from 2007.

Other postings can be found here: Current, 2010, 2009, 2008, 2006, 2005, 2004 and earlier.

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Archived Postings from 2007 on This Page (117):

• i finally had the angioplug removed dec 18th 07,wow what a difference to regain my pulse in my leg, i am for joining a law suit against st.jude and the people that use them.. i can now walk and am in the healing process from the surgery, time will tell how much improvement will be noticeable,only a week under the belt.
Mike, Oceanside, New York, USA, December 26, 2007

• I see where there was some interest in the MedClose Vascular Closure Device being tested. Trials were halted subsequent to a Warning Letter being issued by the FDA.
RJK, California, USA, December 18, 2007

• I can't believe what I'm reading here! Seven years ago I too underwent a right femoral angiogram and a perclose suture device was deployed incorrectly. Horrible electricity type pain shot down my inner thigh and up around my side. I was in terrible pain, was sent home and came back the next morning via ambulance(I couldn't move.) I was on a morphine drip for several days. After an ultrasound a Neurologist told me that there are a lot of nerves in that area and my ileohypogastric and ileoinguihal nerves must have been nicked. After multiple physicians wanting to put a spinal stimulator or use nerve blocks or place a medtronic pain pump in me,etc...I called the perclose manufacturer myself. I was told this is a "nonabsorable" suture device and to have a vascular surgeon go in and remove it. The surgeon saw the nerve running thru the device and cut it out, but after my nerves were strangled for 3 years not much pain has been relieved. I am still in pain daily, and this has greatly limited my once very active life. These devices are only a "time saver" offering no other benefit and I also was not given the option of sandbags, nor was I warned of the possible horrendous complications. The device is deployed blindly by the surgeon into an area with an artery, multiple nerves, and a vein. And from what I have read the doctor may as well cross his fingers and hope it goes only into the artery and close it completely. If not many problems, even life threatening ones can occur. These devices need to be removed from the market. It is the blind deployment, not the device itself, or the negligence of the doctor. How can this be stopped?
Donna Hoskin, R.N., Pennsylvania, USA, December 17, 2007

• I have a question about the starclose "thing" for a lack of a better word. I better back up and give some background info. Last Dec. I was told that I had had a heart attack, I was 33! People around me told me to have a heart cath to make certain that there was no damage. I had the heart cath done, the doctor said everything was fine and then as they were closing me up I heard what sounded like a staple gun, then another. Later when I was back in the recovery room I was given a pamphlet about the Starclose. So my question is should I have heard the "staple-gun" twice or just once??? Oh it has almost been one year and I'm still having discomfort and pain!
Nancy Baughman, Gallipolis, Ohio, USA, December 16, 2007

• i had a heart cath done Thursday and my doctor put a plug in it. that was 2 days ago. i cant get it to stop bleeding. i went to er and they said it looked good and cleaned and changed my dressing and sent me home. when i got home it started bleeding again. if this is common, why not just put stitches in like they use to do. this is the 2nd procedure i have had and i never had this problem when stitches were used. I'm also black and blue from the procedure. is this common?
Tony, Patient, New Castle, Colorado, USA, December 15, 2007

• On 12-3-07 I underwent major, potentially life-threatening surgery, with general anesthetic to attempt to remove the StarClose from my right femoral artery. That awful device was put into my body without my knowledge or informed consent on 3-8-07. For more than nine months now, I have NOT been without fear and/or pain for even one minute. Although the surgeon and I saw the unnecessary device on my CT scan in the days before my recent surgery, he was unable to locate it during surgery. He did, however, remove a huge clump of infection/inflammation from my artery, and I have it in my refrigerator in a pathology jar with formaldehyde to send to a private lab. This reduced the intensity of my pain from a 15 to an 11 on a scale of 1-10. Anyway, my pain has still not been addressed. When the current scar is healed, I will have yet another life-threatening surgery to get this thing out of my body. I have no quality of life as is, so it's worth it to me to take the chance to get it removed. -- (Note: this post has been edited for length and content.)
Iris Newbury, Ph.D., Cypress/CA/USA, Ph.D. (i.newbury@yahoo.com) on Wednesday, December 12, 2007

• A.I. from Sweden -- you are describing the StarClose device from Abbott. It's made of nitinol, a nickel-titanium alloy that is widely used in surgical procedures and implants. Only a small percentage of people have nickel allergies (something you can be tested for). You haven't had any complications which is good. The idea behind the StarClose and other vascular closure devices is to avoid complications, not cause them. You shouldn't have to alter your activity level, once healed. If you have questions, you should discuss this issue with your physician, as well as any concerns about the pea-sized lump, which should go away. As for the device being used without your understanding, this is a patient education issue that many on this Forum have reported. When the patient-doctor/nurse discussion about the procedure occurs, it should cover all phases, including the vessel closure.
Angioplasty.Org Staff, Angioplasty.Org, December 12, 2007

• So glad to find this site. I'm currently living in Sweden and recently went through an uterine artery embolization, which is done through the femoral artery while I was awake, but sedated. While I was lying there at the end of the procedure, the doctor says suddenly "And here comes an internal piecing which will close the artery. It will never come out, but don't worry, it won't affect MRI tests." And with that, he clips the artery shut. I was in no shape to think clearly at that point so that I could protest the insertion of anything permanent in my body without prior knowledge, discussion or consent, but afterward became very upset when I read the brochure that they gave me to read AFTER the procedure (printed by Abbott). This is, of course, ethically and principally wrong. I really don't want anything like this be place permanently in my body that isn't necessary - PERIOD! What's this clip made of anyway - I read nickel somewhere in the postings, but haven't been able to confirm. What if I am allergic to nickel? Now, so far I haven't had any major complications (3 weeks post-surgery), but I can feel the lump there, which is the size of a pea and very tender to touch. What happens when I want to work-out and have to put pressure on that area? No, no, no - I want this thing removed!
A.I., Sweden, December 11, 2007

• There are actually several solutions to the issues of problems with vascular closure devices. One is avoiding the femoral artery completely, if possible, by doing the procedure from the wrist, also known as the radial approach. It's a technique first done in the late 80's and is used much more outside of the U.S. -- to find out more, visit our Radial Access Center. While the technique cannot be used for all patients, there are much fewer complications and no closure device is needed. One problem is that it may be difficult to find a cardiologist who is trained in the technique.
Angioplasty.Org Staff, Angioplasty.Org, November 29, 2007

• There is a solution to these issues not happening at all. Ask your doctor for an alternative to a vascular closure device. A company called cardiva medical sells a boomerang that gives the same results without leaving anything in you. I have had family members use this and there is no chance of a device related complication.
NJ, New Jersey, USA, November 27, 2007

• perhaps the following link has already been provided here, but in case it has not been.... http://www.medscape.com/viewprogram/8143_pnt. I "ran across" this article when reading through my Medscape files.
Barb H, a cancer patient, California, USA, November 27, 2007

• Mike G. and Rufus Clifford - Mike, I just saw your September 07 post and it seems we have very similar symptoms as to inguinal ligament, etc. I am currently seeing a pain management doctor. The advice was to have this done before going further with a vascular surgeon, who I've also seen. The pain mgmt doctor has placed me on medication to quiet the nerves (Gabapentin), I believe so that they don't develop into a chronic pathway for pain. It is actually an anti-seizure medicine. I was hesitant but he seemed very informed and believes the cremaster muscle has been affected. I generally believe this will provide some relief but unsure whether it is the root cause or whether the starclose device will need to be removed. I Appreciate any and all additional information anyone has. My theory is that the clip may inflame the ligament and nerves which affects the cremaster muscle and anything in that area. He thought the clip might be touching nearby nerves. It feels to me like the inguinal ligament has physically thickened. I'm encouraged to read about the neurography tests others talked of and will inquire further. Also interesting to read Mr. Rufus Clifford's post from Tennessee about nerves trapped, abnormal and scar tissue, and I'm assuming progress after a clip being removed? Would be interested to hear more from Mr. Clifford as to how he's doing now, as well as confirming it was a clip removed? Thx.
Mark, San Diego, California, USA, November 23, 2007

• My mother has been in the hospital for 14 days. She is taking all kinds of medications. She had an Angio seal device put in her leg and now in so much pain. The pain is so severe. Is there anything that can be done? Like many if not all, you find out after the procedure is done about the angio seal device. I wonder why talk about it after the procedure and not before. My opinion everyone who commented should be paid for their pains and suffering.
Margaret Odhiambo, New York, USA, November 23, 2007

• The Starclose was approved by the FDA on December 22, 2005 -- tip: you can use the search function (left hand navigation menu) on Angioplasty.Org to find information like this). And "cardiac surgeons" is not the right term. Angiograms and angioplasties are done by interventional cardiologists; cardiac surgeons do bypass grafting and open heart surgery. We can't speak to the amount of training usually done. And Kip of South Carolina -- you shouldn't be able to "damage" an angio-seal a month after placement. But clearly something does not seem right to you -- we would suggest pursuing this issue with your cardiologist -- if you get no relief, other specialists that patients on this Forum have consulted are a vascular surgeon or a neurologist. They can do tests or measurements for nerve health and blood flow.
Angioplasty.Org Staff, Angioplasty.Org, November 23, 2007

• When was the Starclose introduced? and how much training do the Cardiac Surgeons receive before they use it? just wondering.
L.C.N., California, USA, November 22, 2007

I'm a 38 yr old male that had a heart cath performed (no blockages) Oct. 29 2007. I too as many were never told of how the artery would be closed. The angio-seal was used. I have experienced a lump beneath the skin where the incision is (still there) Also I had a hematoma a few days after to which I went to the MD for an he said it was nothing to be alarmed about.Two days later I was still having pain in the groin area, numbness and what seem to be bad circulation in the foot. I went to see the PA and was sent to the hospital for a doppler of the leg and groin area which was normal. My leg started feeling somewhat better and three weeks after the surgery I played golf. Since this time I have felt absolutely awful in the leg and groin area. Is there a chance that I may have damaged the angio-seal or shifted it in such a way that it is causing pain (pinching)?
Kip, Greenwood, South Carolina, USA, November 22, 2007

• Toni, Utica, New York, USA. Your posting of February 28, 2007 just came to my attention. I have several postings on this site. I have been in pain and agony since March 8, 2007. Can you please tell me how you are progressing with your lawsuit against Abbott? I'm working on the same thing. Please contact me at i.newbury@yahoo.com. My body is "wasting away," and I have lost 20 pounds of that I did not own to lose in the first place! This experience is very scary. However, I am opting to have surgery to remove the device because my body can no longer cope with it. My life has been turned upside-down and I'm hoping that having the StarClose removed will help me regain my health and my former life. Like so many of the people reporting their experiences on this forum, nothing was discussed with me about any device. No tests were done to confirm whether a catheterization was even needed. I learned about the nickel device being in my body AFTER I was out of the hospital. How can these so-called medical professionals get away with this abhorrent behavior? Are there NO ethical or moral standards? Sincerely,
Iris Newbury, Ph.D., Cypress, California, USA, Ph.D. (i.newbury@yahoo.com) on Wednesday, November 21, 2007

• hi, i'm nick. i had and angiogram via the femoral artery six days ago. the doctor used a starclose to seal the artery. what should i expect at the site and the underlying artery? the doctor was vague (or i was too sedated to understand) the skin is healing well and i have no pain but there is a small lump (1/2") on the artery. is this normal? thanks
Nick Nicolle, Torrance, California, USA, November 16, 2007

• My name is Scot I live in Marietta, Ohio, in May of this year I had a heart cath done. Since then my quality of life is rapidly declining. So is my weight 38 lbs. in thirty days. My right leg is retaining fluid, I have an enlarging mass on my inner thigh, foot is always cold, my breathing is getting more and more labored and my energy level is on the low end. Quite the opposite from where I was for the last two years following my multiple strokes. Whenever I ask my Dr. about any thing that was presented today he walks out of the room, 2 minutes later his nurse said to me "Oh you're still here,your visit ended when the Dr. left the room." I am stuck in "Mayberry" and it seems as if my Dr. is Barney Phife! And they have used the starclose on me. Any suggestions? Please contact me at scotalan2003@yahoo.com. Thank you in advance!
Scot Alan Edgerton, Washington State Community College, Marietta, Ohio 45750, October 26, 2007

• I had a angio-seal placed jan,07,post cardiac cath. The cath was fine. I suffered a strained abductor muscle on the opposite leg due to positioning and no pre med because the b/p machine didn't work. Since this procedure, I have noticed a prickling in the cathed leg in the groin and intermittent pain in my hip, This last week I had excruciating pain in my groin and hip. I ended in the Er And am told it is fluid in my hip. I thought my leg would explode. I have had an MRI, ct x-ray. I still feel something poking my groin. Is some part of this device still there? Would it show up on MRI? Thanks, Tina
Tina, Valley Cottage, New York, USA, October 22, 2007

• Hello, my name is Jill and my mother (Estelle, who has posted here) is suffering from the aftermath of the Angio Plug post catheterization Unfortunately there are so many people with similar complaints and I just need to know how to help her with her discomfort. What can we do at this point? She has been to physical therapy, had numerous caudal blocks, seen her neurologist, has had an EMG which did in fact confirm her original thought that this pain is from the catheterization and plug and now has femoral nerve damage. Okay, lawsuits seems reasonable for all of you. But the bottom line is HOW do I help my mother sleep, rest, walk and get some relief from the pain. Yes she is older, but this is a woman that use to ballroom dance on roller skates and go the the gym. Now she can get out of bed for a limited amount of time, stand for even less time, walk for maybe a trip to the store hanging on a cart or cane and or the stylish walker I and her therapist insisted on getting. She can't find a comfortable position to sleep in. etc..etc HOW DO I GET HER SOME RELIEF other than find yet another doctor that wants to sedate the pain? I think it is unacceptable for the medical professionals to chose this procedure and not have any advice on what to do if you are one of the patients that have a reaction to the procedure and the plug. At this point I need to find a remedy. Thank you for your attention to my comment. I am really frustrated that the only thing we have succeeded to do is to pay yet more medical professionals to confirm that she has suffered damage. Now we need advice on how to make these people better.
Jill, Daughter of Estelle, Ohio, October 20, 2007

• Had MRI neurography done in CA by Dr. Aaron Filler. Found two nerves trapped and others inflamed. Did surgery Oct 7th and found abnormal tissue and scar tissue said came from whatever they put in me. It was the angio-seal device. Doing better now still recovering. If interested I can give Dr. Filler's info for others suffering from this problem. I pray this surgery will restore some type of a normal life again.
Rufus Clifford, Shelbyville, Tennessee, USA, October 17, 2007

• Was glad to find your site - it certainly answered some questions but generated others - on July 20, 2007, I had a mild MI followed by stent placement and use of an angio seal. Since two weeks after have had terrible pain/cramping in right leg after walking 1/4 block, but no tingling/numbness, etc. Physician Asst said that issue should resolve itself. Another two weeks later had a major internal bleeding - source unknown, requiring blood transfusion. (The GI bleed was 10x scarier than the heart attack and subsequent stent placement.) On follow up visit in mid September, the cardiologist was not able to get a good pulse from knee/foot, etc. Ultrasound shows blockage not far from right groin cath/angio seal site. The proposed fix is to go thru left groin around to right groin to perform angioplasty. Am a bit concerned re closure on the to-be-peformed procedure. M.T. in Sacto explained his chief cardio doc believes strongly in Syvek patches. Seems that this might be a viable closure for me?
SS, San Francisco, California, USA, October 14, 2007

• Hello, Over 2 1/2 years into my angio-seal ordeal leg hurts everyday bedridden unable to stay up. Found Doctor in Cal who developed a MRI neurography which actually allows doctors to see the nerves in your leg and groin. Only two of these machines in the country, Penn & Cal. Leaving Oct 1 for test will see doc on Oct 3. If this helps I will let you know as could help many of you as well. I will keep you updated as I have the strength. If the damaged nerves are located increases chance of correcting or when doing nerve block hitting the right nerve.
R.C., New York, USA, September 25, 2007

• i had two med stents june 28 07,all went well except for the angioplug. i am now having it removed because i cant walk more than a 100 feet without stopping and resting. i am a (was a) healthy 52 yr old very strong guy. they are killing me with this new fangled crap. get it out i say,,where is a good lawyer??????mike
mike, long island, new york, USA, September 23, 2007

• On September 10, I had an angiogram. Heart is good, but I bled at the site after 4 hours of lying flat in bed. Within 1 minute after getting up, I bled out. Rushed back to bed for another 4 hours of being flat! Got up the second time, walked 3 minutes, got horrible pain, felt a "pop" and pain even got worse. Great nurse had me flat in seconds, pressure device put on, and rushed to CT scan. I had a 250cc= retroperitoneal hemorrhage ICU for the next 18 hours. It has been 9 days, and just now able to lift my leg and not walk holding on to my abdomen. I am really upset, and feel that something went wrong with the insertion. Any ideas?
Carolyn, New York, USA, September 19, 2007

• Today is 18 Days post Cath and it still hurts like #$@%. Stayed off my feet All weekend with heat applied and motrin every 6 hours as directed. I filed a report with the FDA today but after reading this forum, I have no idea what to do next. Wish I would have read about this device sooner! I am an active 44 year old and mal. I am praying this has not altered my life forever.
James M Kober, Ocean Springs, Mississippi, USA, September 17, 2007

• 2 weeks Post Heart Cath with Angio-seal Device. I have severe pain in the groin area around where the seal was placed. Pain started almost 1 week to the day after insertion. Notices medium sized bruise the same day. Since then there has been terrible pain in the hip, inside leg, groin and lower stomach. Doctor said, "don't know why you are in such pain, this looks great... best one I have ever done" He did order a ultra sound that was normal. He basically told me to tough it out...take some Motrin if needed. I explained I was in bad pain and he just said "well you shouldn't be, I can't explain it, Hopefully it will get better in a week or two" He said not to worry, its not life threatening. Please help. If anyone has discovered how to minimize this pain. I suspect is the Femoral nerve that's being aggravated but not Positive. I am lucky as I had no Blockage and did not require a stent, its just now I can't hardly walk, sleep or sit without severe pain. These possible side effects were never discussed prior to or mentioned even now with so much pain. I have been taking Lortab and Motrin which only takes the edge off a very little bit. I have to believe the Doctors are getting kickbacks from the manufacture of these angio-seals. I just can't believe with all that I have read here that they would do this to us just for a small profit. How can we trust any of them to treat us?????
James M Kober, Ocean Springs, Mississippi, USA, September 13, 2007

• Just a follow-up to my case. I reported my experience/problems to the FDA. If they get at least two reports and based on those reports they will investigate. The more complaints they get the better we will be. I encourage each one of you to please file a report with the FDA so that one of these will happen. 1. Patients will be informed prior to surgery of the devise being used. 2. Further research into complications will be done. 3. They will be pulled from the market at least until further investigations are done. The process will take about 5 to 10 minutes to fill the online form out. Here is the link for those that need it. http://www.fda.gov/medwatch/report/consumer/consumer.htm
Suffering, Mississippi, USA, September 12, 2007

• I had a heart cath done Sept 4, 2007 and was told before the procedure I would have to lay still with a pressure weight for 4 to 6 hours after to stop the bleeding. After surgery I was taken to recovery and handed a pamphlet about "StarClose". NEVER was this mentioned to me prior to surgery. Well that night I of course had pain and it continued. On Friday I called my cardiologist and he said to go to the hospital for an ultrasound. (Actually this is the short version) so I did. I noted then about the redness and itching that I was having. This continued to get worse and is getting worse. Now my whole groin area is red/inflamed/blistered/itchy/rashy. It is miserable. I have severe pain in my right leg with a twitching like a muscle spasm. I went to ER today and they literally BLEW IT OFF!! Prescribed pain pills and sent me home!! I still can't believe this thing was put in me without my knowledge. And now it is causing me problems. Calling the cardio again tomorrow.
Suffering, Mississippi, USA, September 11, 2007

• I am 56 years old runner (have run on a regular basis since age 15) and have had two angiograms in December 2005 and December 2006. The practitioner used a biodegradable seal device the femoral artery in 2005. Generally, I had few problems and was running again within a week. In 2006, the practitioner used a titanium star close device. Again, I was running again within a week, and initially I liked the star-close device better. However, after nine months with the star-close device, I can say it is substantially inferior the biodegradable device. The pain is getting worst month by month. Can the star-close device be replaced?
G., Florida, USA, September 5, 2007

• Mark, I had a heart cath in February 06 and an angioseal was used. Ever since then I have had swelling and pain in my groin area that runs from my crotch sometimes in my right testicle to the top of my hip and find it difficult to sit straight up in a chair due to the swelling of the Inguinal ligament. I complained to my cardiologist for a month after the procedure and there was denial on her part. She ordered a sonogram to see if there was a hematoma and there was not. All she kept saying was there was not a problem and the "discomfort" would go away. I had my family doctor call and talk to her and she says there is nothing wrong. I had surgery to see if the lymph nodes in the groin were swollen and do a biopsy. The lymph nodes were not swollen and the surgeon reported inflammation around the Inguinal area. I am making an appointment with a vascular surgeon to try to resolve the problem and a pain management doctor to try to get some relief from the pain. Does anyone know of how this problem can be resolved? It seems that the doctors that know my cardiologist have nothing but praise for her and all of them seem to be in denial about a problem existing.
Mike G., Texas, USA, September 2, 2007

• Here's a progress report on my Angio-Seal done July 31st. I feel almost entirely healed but I have hematomas slowly getting smaller. Two weeks after the angiogram my right leg became swollen and too stiff to walk normally. I continued to walk but had to elevate my leg often to reduce the swelling. I continued to be active (picture me lying down and elevating my leg at every tee for 9 holes!) and now the swelling is just about gone. Over the last two weeks it has been reduced in the morning and then maximum in the evening. My doctor ordered an ultrasound of the groin and leg which showed no clotting. He said the swelling was due to the hematomas on the right side impinging on my veins, thus causing a backup. I hope this is correct and that it helps someone else. At this point the doctor could say anything, since I have self-healed. I am now taking hawthorn, garlic, and co-Q10 to keep my BP and pulse low, and to try to rebuild my heart muscle. I was prescribed bisoprolol and lisinopril, but I'll have none of that if natural remedies continue to work. Anyone have experience with these?
Bill G., Self employed, California, USA, August 29, 2007

• I can not believe what I am reading here! I too am having problems with this Angio-Seal device. I had no idea what this was and only found out about it after the procedure was done by being handed a pamphlet. Had I have read stories prior to surgery, I would have opted out. (Kinda hard to do when you are already going out!) At first, I just thought it was me but after talking to numerous people who had angioplasty saying they were fine in a couple days, I realized something isn't right. Has anyone heard of a class action lawsuit yet? This is crazy that they would allow such a device to remain on the market with this many people hurting!!! Please contact me at kakie81600@hotmail.com if you have any information.
CM, Jefferson City, Missouri, USA, August 26, 2007

• I was recently hospitalized for a GI bleed related to taking too much ibuprofen on an empty stomach. They were having a difficult time determining exactly where the bleeding artery was, and finally determined that it was located in a 'pouch' that was created when I had a nissan fundiplication for GERD (ten years ago). Since they were unable to cauterize during an EGD and I kept needing transfusions (13 units of blood and 2 of fresh frozen plasma) they decided to take me to the cath lab and see if they could fix it that way. They went in through my right femoral artery and used an angioseal. This was over 12 days ago and although it was tender, everything was fine until approximately 4 days ago when the lump, which was smaller than a pea, became the size of a peach pit overnight. I also had a temp of 100.8. The area is a little red, but there is no bruising. I contacted the cath lab and they told me to go to the ER, where they would need to do a test to see if the site was bleeding. Since the hospital where the procedure was done is over an hour away I went to a local hospital, which is very small. The ER doc barely looked at the lump, he felt it for a few seconds, then he ordered a CBC. Even though my WBC was okay he said he thought I had an infection. He gave me an antibiotic injection and a prescription for Keflex and told me to apply heat and follow up with my family doctor on Monday. The lump has gotten a little larger since then, and it is still very painful. I'm beginning to wonder if I should just go to the ER at the hospital where the procedure was done. I'm kind of confused as to why this doctor didn't do any type of tests to see what was going on with the lump itself. Does anyone have any ideas about what this could be? I'm starting to get a little worried.
T.J. Parker, Illinois, USA, August 26, 2007

• Mel -- we have heard of seals coming loose which might happen if they weren't placed precisely, or if the patient might have coughed hard or stressed the area in some other way. This would normally occur shortly after they were placed -- once the collagen "sets" the plug should be stable. But as you can see from this Forum Topic, each vascular closure device carries its own set of complications.
Angioplasty.Org Staff, Angioplasty.Org, August 24, 2007

• A patient was angioseal in cath lab under our care. Later i was in A&E (Accident and Emergency) where upon i saw the patient. it became apparent that the seal had popped. can you explain why and how. never had this problem before.
Mel W., Hospital, UK, August 24, 2007

• F.N. -- a vascular surgeon is actually a subspecialty of general surgery -- and many general surgeons perform "vascular surgery". It depends on your location -- your best bet is to find a surgeon who might have experience with this type of repair. You might try searching the Society for Vascular Surgery database to get a referral in your area.
Angioplasty.Org Staff, Angioplasty.Org, August 23, 2007

• June 1, 2007 I had a heart cath with "Taxus Express2" medicated stent placed in left anterior descending artery. Femoral artery was closed with "Star Close". Within 3 hrs. Star Close failed resulting in profuse bleeding (hematoma the size of my hand) and pain which was attended in hospital. Next day I was sent home where I discovered huge blisters at the insertion site. 12 weeks later still have not healed and have pain in groin, leg and hip. Also have numbness in thigh area. Cardiologist stated he had 3 failures with Star Close within 30 days and has discontinued using it and pulled it from lab. No pre-op discussion of closure device to be use occurred. He has referred me to a general surgeon for evaluation. Shouldn't I see a vascular surgeon?
F.N., Mississippi, USA, August 23, 2007

• Joe -- you correctly notice our repeated mentioning of the transradial approach as an alternative to the usual femoral puncture. We're mentioning it often because of the over 300 postings on this topic about complications from femoral punctures, and because radial is a technique that is vastly underutilized in the U.S. If you visit our special section on "Radial Access", you'll learn more about it -- and why it can be useful. However, we are not advising any patient that they must do the radial approach. We're only suggesting that they ask their cardiologist if they might be a candidate. Most cardiologists in the U.S. are not trained in this technique, but we're hoping that this will change. Radial access is used in 30-60% of all angio cases outside of the U.S. -- and the complication rate has been very low -- less than 0.5%. But not all patients are candidates for radial. Also, you point out that you had no problems with the femoral approach, and you have company: 90-95% of femoral patients have no complications.
Angioplasty.Org Staff, Angioplasty.Org, August 23, 2007

• I am curious about the advice given by the "Forum Editor." It is interesting to me that they consistently give the advice of having the physician do a radial approach. When I had my heart cath, I did a lot of research, the radial approach is hardly ever used in the US. Why do you suggest the radial approach so strongly? When I had my procedure they put a device with a belt around my hips and used a pump to pump it up and place pressure on the site. It seemed comfortable and I haven't had any pain or problems since I left the hospital.
Joe, Boston, Massachusetts, USA, August 23, 2007

• Deborah -- there are many papers written on potential complications from vascular closure devices. There is also, of course, this Forum Topic.
Angioplasty.Org Staff, Angioplasty.Org, August 23, 2007

• I had a heart cath done in December 2006 as a prerequisite for disability (meaning the State paid for the visit. I have no health insurance of my own.) Since then I have had miserable swelling in my right leg that does not respond to any diuretics, compression or anything else. Every time I go to the local clinic, I tell them I think it's a complication from the cath and with the angio-seal. (I've had angiograms before the old-fashioned way and had no problems at all). Now I can barely walk because of the swelling and no one takes me seriously that there is a problem. I just get blown off. Does anyone know of any documentation that I can take with me to show the State so I can get seen by the same doctor again to address this problem?
Deborah B., Washington State, USA, August 17, 2007

• Bill G. -- St. Jude Medical, the company which makes Angio-Seal, includes the following language in it package insert (also available on their web site.

"The safety and effectiveness of the Angio-Seal device has not been established in the following patient populations: ...Patients who have known allergies to beef products, collagen and/or collagen products, or polyglycolic or polylactic acid polymers."

You were certainly correct to inform the hospital personnel about your beef allergy -- unfortunately this information did not translate into your having a different closure device, or just manual pressure. Have you seen an immunologist or other allergy expert? They may be able to relieve some of the symptoms.
Angioplasty.Org Staff, Angioplasty.Org, August 17, 2007

• I had an angiogram done July 31st with the Angio-Seal followed by at least 8 days of work-stopping pain. After 12 days I can finally get up without too much pain, but now my right leg is swelling. I can reduce the swelling by elevating the leg. I have a hard place under the skin near the angio puncture site and extending to the right; it feels like a small but full toothpaste tube implanted under there. Also, just 3" above I am very tender and can feel a hard area deeper inside. Are these blood clots (hematoma) that formed between the belly muscles? I can detect and odd smell to my urine and perspiration...is this my system ridding itself of the hematoma? Here's the kicker: I am allergic to beef and I told them that on the morning of the angiogram. Only on this site have I found that the Angio-Seal may be made of bovine tissue. With at least 50 days to go before the Angio-Seal is supposed to be absorbed, what are the chances I will reject the seal and start bleeding??
Bill G., Self employed, Illinois, USA, August 12, 2007

• Hello again...I'm Iris Newbury, Ph.D. from California. My e-address is dr-newbury@ca.rr.com. I would love for people who are suffering (due to narcissistic MDs who inflict unnecessary procedures, devices, and pain upon us) to communicate with each other. I just passed the 5-month date (unnecessary cath done March 8, 2007 because the MD needed a hole to plug since he had "learned" how to just 7 days before my procedure) of having the quality of my life destroyed. I'm continuing to see specialists outside Kaiser-Permanente to explore getting this StarClose device removed. I trust none of Kaiser's MDs now. On the one hand, they have prescribed me 15 prescriptions for pain and for the high blood pressure, etc., caused by the pain. On the other hand, they don't believe that there is any problem, writing me off as a "neurotic female," no doubt. Acupuncture gave no relief after 5 sessions, so I quit. Now, I'm getting two massages a week, and that helps some, temporarily. Please read the two messages I left earlier. My pain in entire leg, hip area, buttocks, and right arm continue. The device is made of nickel and titanium and causes numbness in my arms during the night. Have any medicines helped you? Please let me know how you are getting any relief. Thanks. Please respond.
Iris Newbury, California, USA, August 10, 2007

• I'm a 31 year old female with wpw and a leaky mitral valve. When the wpw was discovered they sent me asap to have a ablation done. I ended up with three punctures, one on the right side of my chest and in both sides of my groin. They used pressure bandages. Had no problems with any of the sites although the site on my chest hurt the most right after, it went away a few days later. This all was done three years ago. It was unsuccessful. Anyway I'm still having chest pain and stuff so my new cardiologist did a heart cath three days ago and they used the angio seal. It hurt while the doc put it in but then subsided as soon as he was done. I have a little trouble sleeping (getting comfortable) I have no bruising and the soreness is subsiding, and I'm finally starting to walk upright. The only issue I have now is the site itches like crazy, I'm allergic to band aides and tape and I think that is why I'm itching so much. But if I ever do have a cath done again I will definitely lay still for hours on end instead of having the seal done. Yes laying still may be agonizing but I was much more comfortable in the days after the cath done the old fashion way.
W.W., Pennsylvania, USA, August 8, 2007

• Teri -- there are several ways in which your situation might occur. Sometimes the angio-seal or other device may work fine, but a small puncture got made on the backside of the artery which wasn't sealed. Sometimes the seal pops out or leaks, as your doctor thinks happened. It's one of the complications of making a femoral puncture. Although your case has been done, for our other readers, we would just suggest two things -- and both of these need to be discussed with your cardiologist because there may be specific reasons why they aren't recommended in your particular case. One -- exams using 64-slice CT angiography have been shown to be over 99% accurate for ruling out the presence of coronary artery disease. Such an exam takes under 15 minutes and is non-invasive -- no arterial puncture, just an IV. Two -- a growing number of hospitals are offering the alternative of transradial access, using the radial wrist artery for the angiogram, which significantly reduces complications such as Teri's.
Angioplasty.Org Staff, Angioplasty.Org, August 7, 2007

• I had an "angio-seal" after my heart cath on July 26th. I also did not know this was going to be used. I ended up in the Emergency Room this past Sunday, Aug. 5 because I was bleeding profusely. The ER doctor said that a stitch had probably worked its way through, causing a hematoma which burst. I lost quite a bit of blood. The incision had healed quickly but now I'm still seeping blood. Prior to Sunday I had so much pain since the day after surgery. I had to have the heart cath (which turned up nothing) to clear me for a hip replacement surgery which was supposed to be today but has been postponed a week until this heals. Really messed up my schedule! I'm only 46. I think this device needs a little more refining and a patient should be aware of its use before surgery so they can decide if it should be used. I never would have approved it!
Teri S., Michigan, USA, August 7, 2007

• Julia and Deborah -- we can understand your frustration and would like to add a few pieces of info. First, almost a third of angiograms are negative for heart disease. They are performed in order to further investigate findings from stress tests, etc. which, often in women, are inconclusive. Within the past four years, 64 slice CT angiograms have shown excellent results in screening out CAD -- and with none of the invasiveness of a standard cath. However, specific guidelines have been developed as to which patients are good candidates for CT. Finally, closure devices are used to help the patient ambulate (walk) sooner. They are not expensive and add little to the hospital's (or physician's) bottom line. For an alternative, watch for Angioplasty.Org's new section on "Radial Access" which describes an alternative to caths and angioplasties from the groin/leg artery.
Angioplasty.Org Staff, Angioplasty.Org, July 31, 2007

• During the middle of July 2007 I had a Angio-Seal (St.Jude Medical) placed at the site of my heart cath. The next day I found myself in the emergency room in horrid pain. Given morphine and checked over I was sent home on Demerol and a pat on the back. I have two times since called my hearth doctor and have been pushed off to the phys. asst. in the office. I have swelling, bruising and pain in the right leg, hip area and many other problems from this. I went for a diagnosis and now have another problem. I am a very active 55 year old person..I can hardly work. I have been told I am an exception--I should be glad my leg has a pulse and isn't turning blue!!! I am now to take tylenol or advil.. and I guess wait? I did not know this was being put in me! I will be going back to my regular doctor who I hope I can trust and show him what is happening. I am now finding out all I needed was some compression at the site. Comments please. Thank you.
Deborah, Pennsylvania, USA, July 30, 2007

• I had a heart cath 4 yrs ago w/angioseal at Stanford Hospital. Shortly thereafter I developed pulsating in the whole leg, and then pain started and continues to increase, along with a lump next to the puncture site. The pain is in the groin and radiates up into the hip and buttocks. Ultrasounds show no pseudoaneurysm and CT scan shows nothing. I don't know if it is a neuroma, or a femoral hernia, but it has destroyed my quality of life and these things should not be allowed to continue. Naturally, they tell me there is no connection, however, I know that is untrue. Ironically, as so many of these people state, there was no problem with my heart, therefore, I have been given this problem for no reason, except to add money to coffers of the Dr. and hospital. The term is "Iatrogenic", which means "problems caused by a Doctor"! The Hippocratic oath states "first do no harm", but I don't believe many Drs. remember this part. What is uppermost in their minds is "don't admit anything, and hide the problem"! For them it is a "hypocritic" oath. I am not usually into litigation, however, to be left with this problem is unforgivable, and something should be done to stop the use of these closure devices!!!!!!!!!!!!!!!!!
Julia P., San Francisco, California, USA, July 23, 2007

• My name is Becky and I had a heart cath. on June 28, 07 A Angio-seal was used and since that time my thigh and the sight of cath. feels like icy-hot was put inside my thigh. I'm going back to the Dr. in a couple days. Has anyone else had this sensation. Thanks for all the info.
Becky D., Ohio, USA, July 14, 2007

• Brenda & Roy -- as you can read on this Forum, each closure device brings along its own set of complications. M.T. from Sacramento says his cath lab uses the Syvek patch, which they find has lower bleeding complications. Of course, not all complications are caused the the closure devices. In your cases, it sounds like the angioseal may have migrated into your artery and caused a blockage. These events are pretty small in number, but not if it happens to be you. If another intervention is necessary, certainly inform the cardiologist about this event, but there's no higher risk for a second problem to occur as there was for this one. However, he/she may want to use a different closure device or none at all. There is also another method, called the radial approach, which uses the radial artery in the wrist/forearm. While not indicated for everyone, procedures done this way do not need any closure device and the patient can sit up and walk right after the procedure.
Angioplasty.Org Staff, Angioplasty.Org, July 13, 2007

• My wife had an angiogram in May 07. An Angio-Seal device was used to seal the insertion site. She suffered symptoms of pain in that leg which began at the insertion site a few days later. A month later a 90% blockage was found at the site caused by blood which had accumulated under the inner lining of the artery at the insertion site and clotted. Vascular surgery was performed three days later to remove the clotted blood and patch the artery. Thanks to skilled and honest Doctors a month later it appears that She will not have any further problems. I suspect others have suffered similar problems due to improper deployment of the Angio-Seal device but have not been able to get the rapid and accurate diagnosis that we were able to get. I believe that these devices have design deficiencies. Our Doctor has had several similar failures when using these closure devices and has discontinued using them.
Roy B., Arizona, USA, July 9, 2007

• To avoid all complications, ask your doctor to use the Syvek patch to obtain hemostasis. There is no need for these devices. Syvek can be used in all patients, even those on anti-coagulation. My Chief of Cardiology is convinced on this product, and so are we... the staff. Hold time is about 10 minutes at most. No complications. Company has claimed it has been used in 2 million patients. One study I know of on 1000 patients showed no complications, even in patients on anticoagulation therapy. Great for techs/staff that used to hold pressure for hours!
M.T., Sacramento, California, USA, July 9, 2007

• Hi -- I had my second cath done in June 2007. The procedure went well. I had the angioseal put in. 24 hours later I underwent a 5 hour surgery to remove the angioseal because my artery had been nip. I don't know what scared me the most. The 5 stents in my heart or the fact that this procedure might have to be done again and if so what are the chances of this happening again.
Brenda, Massachusetts, June 30, 2007

• Jennifer, See my post in "Complications from catheterization, angiogram or angioplasty (nerve damage, bleeding, etc.)?" section. As I had somehow a similar experience. If your numbness is related to exertion of the leg where the angioseal is used (e.g. walking up a ramp), it may be important that you have a vascular surgeon look at it. he may order a special ultrasound to check the blood flow. btw my GP did not know and I had to search the net to find similar incidents!
Frank Hal, Sydney, Australia, June 30, 2007

• Steve -- an allergic reaction can occur from any number of things -- if your Dad was given any new medications, for example. Was this a stent procedure? If so, he was probably prescribed clopidogrel (Plavix) which can cause a rash. But by no means should he stop taking this. It's quite critical for stent patients to stay on antiplatelet therapy. Discuss this with your cardiologist.
Angioplasty.Org Staff, Angioplasty.Org, June 25, 2007

• My Dad had an Angio-seal operation six weeks ago and has developed a very itchy rash which his G.P. has prescribed cortisone creams to ease the itching. My question is;what could he be allergic to and is there anything that he can do to improve his situation?I have reservations about long term use of cortisone creams as they can make your skin become thinner if used over prolonged periods. I would appreciate any help as his doctor can't provide me with any.
Steve B., South Australia, June 23, 2007

• I had an angiogram in December 2006 and a star close device was used. Soon after I developed a hematoma into my scrotum and had to stay in hospital two days.The large swelling did not go down for a month and even now has left some residual swelling in my scrotum which is sore. I have been told this is rare so has anyone else suffered like this? I now have to see a urologist.
Paul B., United Kingdom, June 21, 2007

• I had a heart cath with an angioseal closure in January 2007. Four weeks after the procedure I went for a follow up visit with the cardiologist and complained of numbness in my leg and arm. He said it had nothing to do with the angioseal and to see a chiropractor. Five months later and many adjustments, massage therapy, physical therapy, and acupuncture, I still have the same symptoms. I have been reading everyone's issues, but no resolutions...Anyone out there getting relief??????
Jennifer, New Mexico, USA, June 8, 2007

• Hi, Donna [April 2, 007] -- It is now 6-4-07 and that is 13 WEEKS since an UNnecessary cardiac cath was done on me. (I had a GI problem that should have been addressed first.) I found out from Abbott Labs that the "jerk" (my term, not Abbott's) who performed this cath on me learned to deploy Abbott's StarClose into an acrylic simulated artery just 7 DAYS before he "did" me! His "training," by a sales rep from Abbott, consisted of a 5-minute video and then his deploying/shooting 3 of these dreadful and unnecessary devices into the simulated artery! Can you believe it? This shocks me. Essentially, I became a "lab rat" for a medical person whom I consider unethical. I didn't even know the object was in my body until I was discharged from the hospital! I'm getting sicker, not better. The pain has not gone away. Almost thirteen weeks (88 days so far) of solid pain. My right leg is totally involved in pain and tightness, also my lower back and buttocks. My right arm is also tight and painful. My former active life was stolen from me on 3-8-07. Lymph nodes are popping-up on my body at various places including a breast lump, subcutaneous. I don't know whether these nodes are a trauma reaction or an allergic reaction (StarClose is nickel). I feel nauseous much of the time. I want this object OUT of my body! Please, Somebody, respond with the name of a vascular surgeon who is familiar with removal of StarClose. Abbott Labs has offered me an MD name in Chicago area, BUT I must sign a release clearing Abbott first... This seems cold and uncaring to me, to say the least. Unethical? You decide. Also, I'm in California, not Illinois, so you would think that Abbott AND the FDA would have considered MDs available in EVERY state to do surgery to REMOVE these, BEFORE the thing was approved, in the event of adverse reactions! But, what do I know, I'm just here mourning the active life that was robbed from me and doped-up on pain meds. Your help will be greatly appreciated. Contact me: dr-newbury@ca.rr.com
Iris Newbury, Ph.D., Garden Grove, California, USA, June 4, 2007

• Diana -- did your cardiologist use a vascular closure device like Angioseal?? Sometimes, the collagen causes an allergic reaction -- it is supposed to dissolve within 60-90 days.
Angioplasty.Org Staff, Angioplasty.Org, June 1, 2007

• i had an angiogram in march 2007 i have noticed a knot about two inches from the site could this be caused by that procedure.
Diana M., Arizona, USA, May 29, 2007

• Mark -- what you are describing might be nerve related because the nerves extend up and down the length of the leg. Have you seen a neurologist? Neurologists can measure the conductivity of the nerve to see if that may be the problem. Nerve trauma resulting from a femoral puncture during an angiogram or angioplasty is a known complication, although low in frequency. It may or may not be related to the type of closure device used. See our related topic on "Nerve Damage or other Complications".
Angioplasty.Org Staff, Angioplasty.Org, May 20, 2007

• Update - I did a post here in October of 2006. I had a starclose clip used to close off my femoral artery after an angiogram in May of 2006. One year later I am still having pain in this area. I've had a few followup doctor visits. A tech who did a sonogram told me blood flow was fine and some people feel a knot in this area like a marble for maybe a year. I saw a vascular surgeon who said I should go to pain mgmt and see about numbing the nerve. If that didn't work they could operate to cut out the clip. But I am concerned about how risky that might be after reading of a man on these posts who died three months after vascular surgery. Any additional info anyone has is appreciated. Symptoms are pain and what seems to be a swelling of the inguinal ligament running all the way up to the hip with pain up at the hip also. Additionally a tightness in the whole area in the crease of my groin and a feeling of pain right in the spot of the puncture. Sometimes pain in the testicle. Not sure if there could be any allergic reaction to cause ligament to be tender. Question I'd have for forum editor is, if it is nerve damage, why would I have pain along the ligament all the way up to the hip? Some days aren't bad. Then it seems to hit a spell with a fair amount of pain for several days. thx.
Mark, San Diego, California, USA, May 19, 2007

• Angela-Please see my previous post regarding angioseal. I was told that in the fall of 2006 they had redesigned them and that there was a design flaw with them. I eventually had to have mine surgically removed, and am considering a lawsuit against St. Jude's as I am still having difficulties.
Janeen Jackewicz, McHenry, Illinois, USA, May 11, 2007

• Angela -- the collagen plug in the Angioseal is supposed to be absorbed by the body in 60-90 days. You're past that point now. This might be some type of allergic reaction, some people are allergic to bovine collagen, but it might be something else. Have you seen the interventional cardiologist who did the procedure? If so, what did he/she say? Another specialist you might consult is a vascular surgeon. It should be possible to image the area and determine what the problem is.
Angioplasty.Org Staff, Angioplasty.Org, May 3, 2007

• In December 2006, my husband had an arteriogram done. After the procedure they told us they had used an angio seal collagen plug. He developed a hard knot in the groin area and had shooting pains. Here it is four months later and he has this bulging boil looking thing protruding out in the groin area. It has been draining fluid. We went to the doctor to be put on antibiotics but they didn't seem to know what it was protruding out and why it was doing this. A couple of days ago we went to a different doctor and this doctor thinks that the collagen plug did not dissolve and his body is trying to reject it. They put some silver nitrate on this bulging skin. Help! can anyone explain to me what this is protruding out in my husbands groin. Why did this happen? Has this happened to anyone else?
Angela Carr, Pickton, Texas, May 2, 2007

• Kaiser Permanente did a cardiac cath on me altho' one was not indicated. Had upper GI issue, not heart. That was 3-8-07. Prior to that, I walked 7-10 miles a week, ballroom danced often, was a downhill skier. Never had a pain in my legs in my life. Since that date, my blood pressure has been dangerously high, often 218/108, for example. My leg pulls and pains with every step. Tight band around thigh and calf. I feel sick, am afraid to exercise, and am living on pain, sleep, and b.p. meds since 3/8/07. StarClose by Abbott Laboratories used without my knowledge or consent. I want it out! Can that be done? If so, your Vascular Surgeon referral appreciated.
Iris Newbury, Ph.D., Private Practice Psychologist, Garden Grove, CA. USA, Ph.D. (dr-newbury@ca.rr.com), Thursday, April 26, 2007

• Donna -- the FDA has a page of possible ways to report problems -- by phone, fax, email, or by filling out a form. Rather than go through the time of filling the form, maybe you might send them an email asking if this information would be of any help. Again, we're very sorry to hear your story.
Angioplasty.Org Staff, Angioplasty.Org, April 5, 2007

• Yes, this incident happened in the fall of 1998, and the cardiologist told us, a month after the vascular surgery, that they had discontinued using the Vasoseal at the Medical Center because of my husband's problems. They seemed quite nervous about it. I do believe that the trouble with the vasoseal was a contributing factor in my husband's death 3 months later at the age of 47, especially as the cause of death was so vague. Looking back, I see that I was too traumatized to act on any follow-up to see that this was all documented with proper agencies. Since Vasoseal brand is discontinued, would it be of any value for me to report through the MedWatch?
Donna, California, April 2, 2007

• Angio seal did not seal my femoral artery after angioplasty. I ended up getting severe pain in my lower back because of internal bleeding within 45 minutes of the procedure completion. The bleeding was stopped after applying direct pressure for 30 minutes by the nurse. Several days later the hematoma grew to about the size of a golf ball and created more pain than I've ever felt for at least 3-4 weeks. i ended up gong back to the emergency room and give pain pills then sent home to suffer. Consequently,I was out of work for 2 months because of the constant pain and discomfort. A year later I still suffer from the residue of the hematoma and has since settled in my scrotum bag. On occasion when I am sitting or sleeping to one side I get the achy pain I got when the hematoma started shrinking. I am wondering if the Angioseal is to blame,the doctor, or just bad luck. Your comments would be greatly appreciated as I am considering legal action.
AB, Texas, USA, March 26, 2007

• Mel -- if you gone to your cardiologist, he can best determine if it's a problem or not. Hematomas are not uncommon complications and they often just go away. Let us know how you fare.
Angioplasty.Org Staff, Angioplasty.Org, March 30, 2007

• I went in for a angiogram at Cedars Sinai on 3/21/07 and at the time they installed a medicated stent. The closed with a AngioSeal. After spending the night I went home and all was fine until 3/24/07. That afternoon while stepping three steps I felt a sharp pain in the groin. Soon after that the entry area was bright red and an area just below that on my leg started to get a hematoma. By the 27th the area on my leg had grown to the size of my hand. I have a large hand. My doctor says not to worry. He said this is normal. What do you think?
Mel Cottrell, Glendora, California, USA, March 29, 2007

• Donna -- we are most sorry for your loss. Are you saying there was a connection between this complication and your husband's death? As for whether or not this incident was reported, you would need to ask the cardiologist. Any mortality must be reported, but complications are voluntarily reported by the manufacturer to the FDA. You can also report it directly as a consumer at MedWatch. As for Vasoseal, this must have been a while back because Datascope announced it was discontinuing Vasoseal back on October 19, 2006.
Angioplasty.Org Staff, Angioplasty.Org, March 29, 2007

• My husband had a routine angiogram, and a vasoseal was used in right leg. Within a couple of weeks, he was having major leg pain. Upon return to LLUMC, they determined major clotting around the seal and blocking blood flow. 1st attempt: approaching clot through artery via lower part of leg - failed. 2nd attempt: enter through groin area on left side and go across to approach clot -failed. Referred to a vascular surgeon, had to have part of artery cut out to remove sea and the clots, as well as reconstructive surgery to repair artery. Within 3 months, my husband died. How do I know whether or not the medical center reported this case?
Donna, California, USA, March 27, 2007

• I am 33 years old and had a heart cath done 2 days after Christmas. My cardiologist used the angioseal to close my femoral artery. i went back for a checkup and a blood clot was found on the ultrasound. I started taking coumadin that day. I have been on in nearly 3 months, all of which I could have little salad, no teas or herbs, and no exercise. Each week I went back to have a protime (check my blood to make sure the coumadin was working) Each week I was "out of range" and subsequently, my coumadin was increased. Next week I go back for another ultrasound. I still have the clot and feel like the angioseal has not completely dissolved itself. I will then have to have it surgically removed. I am very nervous because I have small children. Before my heart cath in Dec. they had to give me 3 rounds of "chill out" medicine because I was so anxious. I was assured by my doctor that angioseal was a good product and my complications were very rare. However, after reading this I am convinced this is not so rare.
KB, California, USA, March 22, 2007

• hi, I had cath 5 days ago through the right femoral artery and the doctor closed the artery with StarClose closure device but he never told that he would use that instead of the natural pressure applying way. The first couple of days I had some pain which I thought is probably normal. However, on the 4th night I had the feeling that my body is burning and I had pain in the right (back and front) side and I don't feel good at all. I think that the problem comes from the StarClose closure device. I am going back today to see the doctor's nurse, since the doctor is not there. Please let me know if anybody knows if the StarClose device can be removed and if there will be any complications after removing this closure. Thank you.
Katerina, Indiana, USA, March 21, 2007

• George -- good question. The company that makes MedClose, CPC of America, Inc. in Sarasota Florida, doesn't list any sites where the trials are being conducted. Their latest news release states that ongoing results from their randomized clinical trials are positive, but that's about it. They also state they expect to file for European approval in the next couple of months. A search of clinical trials databases turned up nothing. We'll see if we can find out more -- or if you do, please post the info.
Angioplasty.Org Staff, Angioplasty.Org, March 16, 2007

• in terms of medclose device, does anyone know where this device is undergoing clinical trials?
George Roberts, Chicago, Illinois, USA, March 12, 2007

• FGD -- you should also check out the related topic on "Nerve damage and other complications". The problem may not be the sealing device, but some type of neurologic (nerve) problem -- we're not giving advice, only noting that a number of posters on this and the related forums have reported nerve problems. A neurologist might be able to test this. Has there been any imaging of your leg and thigh, other than the ultrasound (CT or MRI)?
Angioplasty.Org Staff, Angioplasty.Org, March 12, 2007

• I had an angiogram (with Angioseal) in June 2003, at Stanford Medical Center (thinking they were the best). I also was not told about the Angioseal until after the procedure. At day 85 I was awakened with a throbbing pain at the entry site. Shortly thereafter, I began getting several obvious veins on the back of my knee, which continue getting worse and I am awakened in the night with pulsating in that leg and groin, which continues to worsen. I have had two ultrasounds looking for a pseudoaneurysm, but they showed nothing (or so I was told). The discomfort sometimes goes all the way down into my toes, especially the last three. It is now 3 3/4 years later and it just keeps getting worse. (I am writing this at 5:00 a.m., having been awake since 3:30 due to the pain.) I am amazed at what I have read on this site as the Doctors have been acting as if I must be imagining things, even though I told them I feel like a (ticking time bomb). They told me during the angiogram that for my age my arteries looked "marvelous", though I have since read that even these tests are not necessarily accurate on women. This is not the first time I have had procedures which created problems where there were none before. I would appreciate comments, if helpful. Thank you.
FGD, California, USA, March 8, 2007

For Martha regarding the Boomerang: my husband had a rash but it was probably from the elastic tape used to apply a pressure bandage to his groin for about 8 hours! (The boomerang is removed from the body after the procedure, unlike the other devices. Just be sure the person pulling it out deflates the device correctly, PLEASE! Check out the website for Cardiva: there is a videoclip of the proper technique.)
Barbara, Texas, USA, March 3, 2007

• Again i urge everyone to fill out Med Watch that is having trouble with StarClose. We can stop the use of this and save others from our miseries.This cannot be removed and we're stuck with it in our bodies. We'll get farther in numbers. I did contact a lawyer and am going to file a suit against Abbott Labs. My doctors didn't know that nickel was in this product. I'm still not feeling myself, have pain, no energy, and weakness in my leg.
Toni, Utica, New York, USA, February 28, 2007

• I had a heart cath done in July of last year; they used the StarClose closure to seal it. I had immediate pain at the time of the procedure (consensus was that they got a nerve with it) and have had recurring pain such that it keeps me up at night. Docs seem to have nothing to fall back on as to how to remedy it as it is still new???
S, Northern Virginia, USA, February 26, 2007

• In October 2006 I had a cardiac cath, which they then used a St. Jude angioseal to close. Previously I had had a cath with manual compression and no problems. 3 days later I couldn't walk very far without extreme leg tiredness and pain. My foot pulse was very hard to find, and I had numbness in my foot. My doctor spoke with the St. Jude's rep who said they had redesigned the device, and evidently it had broke in my leg, with a resultant clot that they said would all go away in 45 days when it dissolved. 90 days later I had to have femoral repair, and they found the device and much scarring. I subsequently developed a hematoma and neuropathy, which a month later I am still dealing with. Has anyone else had these type problems?
Janeen, Illinois, February 25, 2007

• I urge everyone to fill a report out on Med Watch who has had problems with the Star Close. I did so this morning.
Toni, Utica, New York, USA, February 21, 2007

• Leslie in Pennsylvania, please contact me. I would love to pursue this. Thanks.
Ron, Texas, USA, February 21, 2007

• Hi this is Toni from Utica, NY again. Well now it's Feb 20th and i still haven't healed. I still have the itching along with a rash and pain in my leg, plus i feel ill. I did find out this Star Close cannot be removed. I also am thinking of going to a lawyer and go after Abbott Labs.There is no warning of nickel on its pamphlet i have to live the rest of my life like this. I'm 63 and would like to live at least another 20 without all this agony.
Toni, Utica, New York, USA, February 20, 2007

• We've posted this before -- on the Abbott web site you can read the Instructions for Use for the StarClose. There is no mention of allergic or hypersensitive reactions from the metal Nitinol, which is a nickel alloy. We're not sure why, but will try to find out. Any physicians or healthcare people out there have some info on this?
Angioplasty.Org Staff, Angioplasty.Org, February 20, 2007

Ron in Texas- My mother almost bled to death from a angio seal that popped out -- let me know of any suits or would you like to work together??
Leslie, Pennsylvania, USA, February 20, 2007

• I'm filing a class action suit anyone want to know the results. I've suffered long enough with pain, leg weakness, and feeling ill. I'm allergic to Nickel why Star Close hasn't a warning is beyond me. I was never asked and i'm very very angry. You can call me at [phone number not reprinted to protect privacy of poster -- anyone wishing to contact poster, please request by posting to the Forum -- ed.].
Marie, New York, USA, February 11, 2007

• Hi I had a StarClose used on my angioplasty on Jan 8th. I just learned after a month that this is a metal, which i'm allergic to. Nobody asked i thought it was plastic. For a month now i haven't healed and have a rash at the puncture site. I see my vascular doctor on the 15th again. He agrees the StarClose is my problem. We need to get our medical doctors -- this product is no good. I had 5 heart caths done and never a problem till now.
Toni, Utica, New York, USA, February 10, 2007

• Connie -- as you can read on this and also the related topic on "Nerve damage and other complications" -- you're not alone. Back pain can be caused by the lengthy time on your back in the cath lab and then in recovery. This is something that a chiropractor might help. But pain in the groin and right leg would most likely be related to the femoral puncture. The area needs to heal -- sometimes the nerve is traumatized. If you continue to have groin and right side pain, call the interventional cardiologist about it. For the groin area, you want to rest, not manipulate the area.
Angioplasty.Org Staff, Angioplasty.Org, February 10, 2007

• I had angiogram and angio seal was used on 1-24-07. I had lower back pain right after and still have although not as bad. I also have pain in the groin area and my right side. I have gone to a chiropractor and he wants me to come back--has not seemed to help so far. I am concerned this might cause more problems ;should I go back or do something else?
Connie, North Dakota, USA, February 10, 2007

• Estelle, several studies have shown that closure devices help "ambulate" patients more quickly, that is reduce the time they have to lie flat on their backs in recovery, but so far the studies we've seen published don't show a reduction in the complication rate from femoral punctures -- often quoted at 3% -- over the old-school manual pressure. This may be because the complications occurs in the puncture phase, not so much from any of these devices per se. One possibly growing trend that may reduce complications is the use of the wrist, or radial artery access. It's not possible to do in every patient, and it requires special training for the cardiologist, but the complication rate is much lower, and there's virtually no extended recovery time needed. Unfortunately less than 10% of procedures in the U.S. are done this way (much higher in Europe).
Angioplasty.Org Staff, Angioplasty.Org, February 10, 2007

• HELLO, I am Estelle and I wrote you several days ago [in "femoral nerve damage and other complications"] . I wondered if there was anything new to help me but it seems that newer devices are causing more symptoms than I have. I still have pain, weakness, numbness and electrical type pain and wanted to know if there was some new treatment. Let me know if you can help me. I will read your updates. Thank you for your information.
Estelle G, Ohio, USA, February 8, 2007

• Dear editor. many thanks for your reply. i think i should have posted on the topic, "femoral nerve damage and other complications". following autopsy and inquest the cause of death was, in the pathologist's opinion, "hypovolaemic shock due to hemorrhaging probably due to a tear in the artery". the coroner gave a verdict of "medical misadventure". i would dearly like to know why, while my father spent 8 hours in the coronary care unit, the symptoms of this internal bleed were not observed, and what those symptoms would have been. your website is enormously valuable, thank you.
Denise W., Ireland, February 6, 2007

• Denise -- we're so sorry to read your story. Our deepest sympathies to you and your family. You posted to the topic about vascular closure devices. Was one used on your father?? If so, which one? Did the autopsy implicate the bleeding as a contributing factor in his death? A hematoma should have been visible as a large purple area, but if it was internal maybe not. One would think that a drop in blood pressure also might have occurred. Hard to say from a distance though.
Angioplasty.Org Staff, Angioplasty.Org, February 4, 2007

• my 76 year old father had an angioplasty carried out. following the procedure he complained of pain and was given morphine. i was told he was resting so i kissed him and went home, this was 8p.m. at 3a.m. i received a call from the hospital to come quickly. my father passed away shortly afterwards, despite frantic and prolonged efforts to revive him. autopsy showed he had a large hematoma in the pelvic area. does anyone know if the signs of this should have been obvious to the nursing staff and if so what would they have been? thank you.
Denise W., Ireland, February 4, 2007

• My wife had an angioplasty done and the angio seal was used. Stayed overnight at the hospital. 30 hours later the seal broke loose and she nearly bled to death. Lost over two units of blood. I have heard of this happening to others. Does anyone know of any litigations on this problem? Please let me know.
Ron, Texas, USA, February 2, 2007

• Regarding the postings about the "Boomerang" Closure Tool... Have there been any rash complications from it? I am hypo-allergenic individual and will be having my surgery done soon. I will talk to my doctor about it of course, but I would love to have some info before then.
Martha, Connecticut, USA, February 1, 2007

• Diane -- We would like to reiterate a fact here. There is a known tendency that women with positive stress test results often are getting a FALSE POSITIVE. Women who are concerned with the possibility of complications from an standard angiogram (3-8%) might want to think about getting a CT Angiogram instead. This test is extremely accurate in terms of ruling out coronary blockages and avoids the complications associated with an arterial puncture. As for your situation, perhaps the ER doc has only seen this 3 times in 15 years, but what about your cardiologist? Has he/she actually seen you?
Angioplasty.Org Staff, Angioplasty.Org, January 30, 2007

• I HAD A HEARTH CATH DONE ON 1/11/07 BECAUSE OF POS STRESS TEST, BUT APPARENTLY HEART WAS FINE. WITH ANGIO-SEAL. ON EVE OF 1/12/07 I HAD A POKER HOT TYPE OF PAIN DOWN MY RIGHT LEG. ENDED UP IN ER WITH AN ULTRA SOUND DONE THAT SHOWED A SUPERFICAL BLOOD CLOT, MY WHOLE GROIN AND THIGH WAS PURPLE FROM WHAT THE DOCTOR SAID WAS BLEEDING UNDER THE SKIN . ER DOCTOR STATED HE HAD ONLY SEEN THIS HAPPEN 3 TIMES IN 15 YEARS AND SHOULD BE OK BUT COULD DEVELOPE INTO A DEEP VEIN CLOT. HOW WOULD I KNOW IF I DEVELOPED THIS PROBLEM? IT IS NOW 1/27/07 AND I STILL HAVE EXTREME PAIN, IS THEIR SOME THING I SHOULD BE DOING. MY CARDIOLOGIST PUT ME ON PLAVIX 75 A DAY AND TO SEE HIM IN 6 WEEKS....6 WEEKS SEEMS LIKE A LONG TIME WITH THIS PAIN.
DIANE T, PENNSYLVANIA, USA, January 30, 2007

For Amy regarding the Boomerang device: my spouse had a problem with the device because when the nurse pulled it out of his leg after his heart cath she did not close it so his femoral artery was torn. I posted a note about it in August. This incident occurred at Methodist Hospital in San Antonio Texas. We don't recommend going there.
Barbara, Texas, USA, January 19, 2007

• Tom -- the Medclose device has not been approved for use by the FDA, although the company hopes to have approval sometime this year. When it is approved, we'll report on it.
Angioplasty.Org Staff, Angioplasty.Org, January13, 2007

• I've read about another vascular closure product, medclose, that is in clinical testing. This was compared to starclose in a closure device analysis: http://www.cpca2000.com/mcanalysis.htm Has anyone else heard about this?
Tom Jones, January 13, 2007

• Richard, first of all, nothing written here should be construed as medical advice -- you must discuss your options with a doctor. But we can give you information. There may be any number of causes to your rash and swelling, but it sounds like it may be an allergic (hypersensitive) reaction to bovine collagen, which is the major component of the Angio-Seal plug. Steroids (prednisone) are one treatment for this reaction, and from your post, it seems that prednisone is working. Especially since the rash returns after you went off. Staying on the prednisone may be the option, although it may be having other side-effects on you. You should discuss this with your doctor. We also found this article from 1999. It discusses that cyclosporin was found to be helpful -- although cyclosporin is a heavy-duty drug and has definite side-effects. Prednisone, if it is working, might be better. The collagen plug is normally absorbed by the body -- which is the whole point. Angio-Seal normally takes 60-90 days to fully absorb (at which point we assume the allergic reaction should disappear). Good luck and let us know how you fare.
Angioplasty.Org Staff, Angioplasty.Org, January 11, 2007

• On December 7 I had a catheterization performed which went well. [Artery closed with angio-seal.].... However the next Morning there were rashes all around the site..As each day continued on the rash moved further and further around my private areas.... Calls to the doctor were answered with take Benadryl and cortisone cream. After a couple of weeks my private parts swelled to the size of a hard ball went to Dermatologist prescribed Oxystat and high power Cortisone cream ...Area keep getting more bright red head of penis ect..Went back prescribed Antibiotic Cheplaxin and gave me new creams cortosteriod and bactril...Still nothing went back prescribed prednisone finally after a week and half swelling and rash has subsided..Now as I wean off prednisone the itching and rash are coming back..Cardiologist wants me to stay on prednisone for more weeks..I am Afraid i have gained a lot of weight and my sugar has spiked way up..i would like to remove device he says it is not possible...Any suggestions or help would be immensely appreciated. Thanks rich
Richard Butz, Pennsylvania, January 10, 2007

• Debra, the StarClose clip is made of nitinol, an alloy of nickel and titanium. The StarClose "Instructions for Use" (IFU) do not mention anything about allergic reactions, or caution the physician against using the device in patients with a known allergy to nickel -- a caution which does appear in the IFUs, for example, of stainless-steel devices, like stents. Anyone know why it's not mentioned?
Angioplasty.Org Staff, Angioplasty.Org, January 6, 2007

• I had the starclose clip used on last angio. I wasn't asked or advised before hand. I now have pain in my groin area, warmth in my upper leg. I have an allergy to nickel. I feel tired, I get sharp pains that feel like a nerve is being cut in half. My leg gets tired and It feels like it wants to give out. I had my angio in Nov. and feel like I never healed from it. The area is tender to the touch. Nothing like my first angio. What should I Do?
Debra Barnes, Batavia, New York, USA, January 6, 2007

• To try and illuminate the past few posts -- all procedures that utilize a femoral puncture have a certain amount of complications. The figure most often quoted is around 3% -- a number of people think that these complications, like many "adverse events" are under-reported. Reporting of deaths caused by medical devices is mandatory, but other events are voluntary. Here's how the FDA puts it:

"User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA."

So, for non-death-related events, the way it works is that doctors may file a report, which their hospital may send to the manufacturer, who in turn might send it to the FDA. Consumers may also file a report directly, using MedWatch -- which we've been told by patients is less than user-friendly. So, while hospitals or HMOs may have their own protocols and regulations for reporting, the FDA MAUDE database is voluntary, and the FDA specifically states: "MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices."

So hard data isn't there. What does seem to be true, however, from several studies, is that vascular closure devices, such as as Angioseal, StarClose, etc. do not seem to reduce the complication rate. One reason is that, if the femoral puncture is not ideal to begin with (and this has nothing to do with the closure device) there is a much higher liklihood of a complication, bleeding or otherwise. Abbott Vascular has hoped that the StarClose might be better at resolving some of these complications, but it's still relatively new and I don't know of any specific studies showing this. We'll try to get more info.
Angioplasty.Org Staff, Angioplasty.Org, January 6, 2007

• Are Doctors required to report complications with closure devices, such as an angioseal etc.? Otherwise the 3% complication rate you quote would not be accurate.
D.H., New York, USA, January 3, 2007

• I work in pharmacy, for a large HMO, on the week before Christmas, 2006, I had a stent put into my left main coronary artery. When I was brought back to my room, my daughter noticed that my blood pressure was 66/40. I had a shot of enoxaparin 100mg, in the ER the day before. That day was given 8 plavix and an IV of Integrilin I was discharged the next day with a stent card and an angio-seal card to carry on myself. I had complained of a deep pain in my lower right abdomen, the same side as the cath. The nurse said it was normal. I saw the cardiologist 4 days later complaining of severe burning in my right abdomen and had to sleep with an ice pack on it the night before. The dr told me to call back if it got worse. I called back and he told me to go to the E/R. I was admitted and had a CT and ultrasound. It was positive for a Retroperitoneal Hematoma. My hemocrit fell from 37 to 29.5. The dr.s said that the bleed had stopped. I was worried because I am pumped up on blood thinners. I saw my cardiologist the next day. He apologized and told me that I had experienced some complications. He said that some people pass away from this, but that I would be sore,from the internal bleed, but that in about a month, I would recover. I went home and went on-line and looked up what had happened to me and saw that it was caused by a double puncture to my femoral artery during the cath, which was their error. I was scared when I realized that I almost died. I thank God that I am alive.
Diane B., California, USA, January 2, 2007

• I developed a pseudo aneurysm after Cardiac cath and the use of an angioseal in my femoral artery. A vascular surgeon operated on me and everything seems to be fine. What I want to know is can cardiac cath be done again in the same femoral artery? Also, what is the latest closure device with the fewest complications with the femoral artery after cardiac cath?
D.H., New York, USA, January 1, 2007

• April, the "Instructions for Use" (a PDF is posted on the FDA site) for the StarClose read:

"The StarClose Clip, when used in the MRI environment, has been demonstrated to present no
additional risk to the patient or other individuals, but may affect the quality of the diagnostic
information. Safety testing was conducted on 3-Tesla equipment."

Angioplasty.Org Staff, Angioplasty.Org, January 1, 2007

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