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Angio-Seal, StarClose and Vascular Access and Closure Devices (2010 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 2010.

Other postings can be found here: Current, 2009, 2008, 2007, 2006, 2005, 2004 and earlier.

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Archived Postings from 2010 on This Page (81):

• I had a heart cath performed in Dec 2010. They first performed a TEE (transechocardiogram) then read the info regarding the Angioseal. I was already very anxious and being read this information while on the table is the wrong time. What could I say- what are my choices/options? After the angiogram, I returned to my room I was in a lot of pain they insisted that I walk but there was still so much pain after a few hours, I was released and told to keep the card in my wallet for 90 days. They gave me the required discharge papers and I left. The next day, I went to the kitchen for breakfast and I experienced the worst excruciating pain ever above and below the insertion site. Then a sharp pain shot down the inside of my right leg to my knee. I could nether stand nor sit. I was bent over and screaming that someone get it out of me. I didn't know if it was the seal or the tape the next thing I knew, I was passed out on the floor. I ended up in the emergency ward and released later that day. That next Monday, I returned to see my cardiologist he that I probably passes out from the pain after the anesthesia wore off My mom looked ST me and we both agreed that that was stupid.
MaxT, Chicago, Illinois, USA, December 27, 2010

• Our Patient Forum tends to be a "complaint department" -- we seldom hear of the successes; we always hear about the problems. And this topic certainly attracts the problems! But this topic, and the related topic on "Complications after Femoral Cath or Angioplasty", are two of the reasons that we started our "Transradial Access Center" three years ago -- to help patients avoid these kinds of complications. Doing caths and angioplasty transradially (from the wrist) is done much more in other countries (90% in France, 30-40% in many other countries -- but only 5% in the U.S.) and, while no medical procedure is complication-free, the radial approach has been shown to have far fewer complications than the femoral (groin) approach. Also no closure device is needed and the patient can sit up and walk around almost immediately. So if you ever need another cath, find out if it can be done radially (and use our Radial Hospital Locator to find a doctor who uses this technique).

As for not consenting to having a vascular closure device used, like Angio-Seal, Mynx, StarClose, etc.) our understanding is that in most states, a separate consent for a vascular closure device is not required -- it is covered under the consent for the procedure itself.

Finally, we and many cardiologists we've spoken with, feel that complications and adverse events with these devices are under-reported in the real world, so we urge everyone reading this to report an adverse event directly to the FDA -- go to FYI, the reason vascular closure devices were invented was to help patients ambulate (walk) sooner, as well as make the procedure quicker. And for the vast majority of procedures, they work well, although they do add costs to the procedure (a few hundred dollars).
Angioplasty.Org Staff, Angioplasty.Org, December 10, 2010

• 12-3-2010 Angio-Seal used after arteriogram, blacked out next day from extreme pain in the surgical site. Went to emergency room by ambulance; ultrasound on wound was negative. stayed overnight at hosp. sent home next day. can't drive for 30 days in case of another black out. Pain is about 5 to 6 inches above the site - bending over pain when I walk - trouble sleeping. Is it possible for the seal to dislodge and creep up in the vein? Called doctor twice - unconcerned, going tomorrow and am going to insist on someone looking at this situation. I was not asked about the Angio-Seal prior to the arteriogram - was given the brochure before the procedure and told to carry the card in my wallet for 90 days. Possibility of blood clot?
JWW, Tennessee, USA, December 9, 2010

• I had a diagnostic cardiocath in right femoral artery two years ago and have had chronic shooting sharp pain in my groin. Like many others, I was advised of devices and/or their potential complications. I am now having more severe pain in the groin, knee swelling and it is now locked and won't straighten and now right hip pain. I went to an orthopedic surgeon for my knee and mentioned the cath procedure and groin pain and he said I could not have nerve injury from the angioseal because I don't have numbness or tingling. I am particularly interested to see if the device migrated to my knee like one other person mentioned. After a bone scan, I will be getting an MRI of my knee and maybe we will see something. Not sure what kind of doctor to see about my groin in particular. A vascular surgeon I suppose. I didn't read much about resolution of this problem and the pain, so I am losing hope. I do think the doctors and/or manufacturers of these devices should be held liable. I will be seeking legal advice if the seal is the cause of my problems. It has majorly affected my life, I can no longer work out and have gained a lot of weight and getting depressed about my physical health.
Jill, Memphis, Tennessee, USA, November 26, 2010

• Hello I had a cardiac cath in Oct. 2008 and ended up in ICU with a stent in my vein due to the Angio-Seal not opening correctly, either due to being deployed wrong or defective piece. I continued with pain and swelling for one year and was given different reasons as to why my leg was swelling and painful. One month before my year was up I told the Dr. that if I could take the leg off and beat him with it I would, this finally got his attention and referred me to a neurologist who said I had a femoral nerve injury and to this day am still having problems, and being on multiple meds for the problem. Can not sue cause I can not prove it was deployed wrong so for now I pay the $500 a month meds just for the leg not counting the other problems I have. I will always ask to what will be done and put it in writing on the consent. Very disappointed.
Miserable in Louisiana, Baton Rouge, Louisiana, USA, November 23, 2010

• I also had an angio-seal put in without knowledge before hand and immediately knew something was wrong as my leg felt heavy and "asleep". I asked the cardio he said it would be fine in a few days and come see him in a week. 2 months later and constantly complaining and showing him my leg had atrophied some he agreed on a ultra sound and within a few days guess what Good News we found a blockage its plaque down by your knee and we can do surgery tomorrow I knew then that I wouldn't have him touch me went to mayo clinic in az. and had the best vascular surgeon do the surgery to repair the damage caused by the angio-seal 2 1/2 inches of scar tissue. I now have a 6 1/2 inch incision on my groin area. Yes I am angry at the cardio dr for ignoring me and having the arrogance to say it couldn't be anything he did, so I am in agreement with everyone else that it should be OUR choice whether we want something inserted in our bodies! And if they do put it in they should be held accountable for any repercussions. It's been 4 months now and yes my leg is functional and I can walk distances again but the pain and numbness will never go away completely. Please get second opinion if you have probs
KJAX, Las Vegas, Nevada, USA, November 16, 2010

• Hi! On 11/9/09 I had a cardiac cath with a stent placement. The next morning the angioseal popped and I bled for 1 hr and 15 mins before a cardiologist arrived on the floor to see one of his patients. He was asked to see me. He hopped up on the bed and applied pressure for 30 minutes. I was in intensive care for 5 days and in the hospital for 12. I ended up with a hematoma in the groin 13"x7". I had three blood transfusions. Ever since this incident I am still having shortness of breath and pressure in my chest. I just got out of the hospital two days ago after having chest pains. I want to know if this extreme bleeding could cause some of the symptoms I am still experiencing. A CT of the chest mentions a 5-6mm nodular focus at the attachment of the right major fissure. This could represent a nodular focus of thickening of the fissure or atelectasis. It also states there is mild atelectasis in the lung bases. I was supposed to be so much better after the stent placement and I am not. . I heard the doctor telling the PA to push the seal in until he reaches the white ring I was wondering if this could have been the PA's 1st time he placed a angioseal Any advice Thanks.
Betty B, Sandwich, Massachusetts, USA, November 14, 2010

• I am a 51 year old woman that had a heart cath done july 2010. Heart Cath showed everything was good but Dr used Angio-Seal to close,said it helped shorten time of stay because of the pressure.Was better than manual pressure. I've been hurting in groin area for about a month now and its been over 90 days since I had it done. Dont really want to contact Dr that did the Heart Cath because he hurt me doing the heart cath. Don't really like him.
Phyllis C., Dyersburg, Tennessee, USA, November 13, 2010

• I am 60 and had an angiogram to determine why I 'failed' the tread mill stress test on October 2010. An angioseal was used to complete the procedure. Within two weeks my left foot swelled in response to the blockage on the artery with the seal. I called and my wonderful doctors office ran an ultra sound. I had a 75% blockage due to a blood clot formed next to the seal. I had to have emergency surgery the next morning to remove the clot and put a stent in the main artery in my leg. That surgery was closed the old fashion way, with direct pressure applied to the artery by the nursing staff...In my case, the seal was more hazardous than the surgery.
Annie, Educator, Oklahoma City, Oklahoma, USA, November 8, 2010

• I am a 49 year old female in great health that suffered a heart attack--result of a arterial spasm doc says--to be sure--I had a cardiac cath with an angiogram on oct. 8, 2010--arteries found to be perfect so no stent--I had what I thought was too much pain in the artery puncture area for two weeks--I am still experiencing discomfort -- there's a hard bump that if touched just right hurts and just doesn't feel "right"--it has been ultra-sounded twice--they say looks fine--no bleeding--that seems to be the only concern--nurse finally looked up what the doc had done exactly--report shows a "pro-seal" has been stitched into me--this was not discussed prior to procedure--I am still not to the bottom--I am thinking this thing need to come out before it shifts even more or causes some of the complications I am reading about here...
KUbrenda, Kansas City, Missouri, USA, October 28, 2010

• i had a angio seal and two weeks later i started experiencing problems from shaking uncontrollably not being able to sleep pain in my back burning sensations numbness in my legs jerking i need help i told my so called doctor all this and he more or less says eady have seizures this is going to make it worse i have got an appointment with this quack friday and I'm gonna tell him what's happening AGAIN PLEASE SOMEBODY HELP.
Ken, Grand Prairie, Texas, USA, October 24, 2010

• I am furious to learn that the end of my heart catheterization ended with an insertion of starclose. This insertion was done without my consent. The only way I know it is a starclose is because the bandage covering my wound says the words "Starclose" on it. This device will be in me for the rest of my life. I should have been asked if I allow it first. How can cardiologists get away with this? Is there a class action law suit somewhere?
Al, Apex, North Carolina, USA, October 15, 2010

• I had a fairly large hematoma after my angiogram (Groin to knee). There were a few complications, had to stop the bleeding twice after the surgery, used hand pressure. Now, twelve days later, the hematoma area itches like crazy and is still somewhat sore. Normal?
Itching after angiogram, Arizona, USA, October 9, 2010

• My name is Jack i live in the south east corner of tennessee. I had a heart cath 9-4-2010 i was on the Henry Ford heart cath assembly floor. They brought me back to my little cube told me to rest a while and three hours after the cath said it was o k for my wife and daughter to wheel me to our car. I am a 57 yr old paraplegic and i have been in a wheel chair for 32 yrs. We made it about 13 miles from the hospital and my right leg started swelling and my crotch area was in terrible pain. We went back to Park ridge and i was in the e.r. for 5 hours waiting on my heart dr. he finally came in and put a hudge line of tape around my whole inner thigh area he made everyone leave the room just me and him, strange.They kept me over night and sent me home again. In two days my local m.d. put me in the hospital for seven days. I went home for three days and it happened again. I was transferred back to Park Ridge and the found a aneurysm at the site and had to repair it. This ain't right what should i do? I am in constant pain, my leg is hudge and nobody cares. I need help
Jack C, Turtletown, Tennessee, USA, September 20, 2010

• My mother had a Cardiac procedure which she was given the risk of angio procedure after the procedure She signed a consent for the angio procedure but no such consent signed for the risk benefits of the angioseal procedure itself. With no no known knowledge..for the angio plug and in a stressful state she followed her dr advice and went with what he suggested. less than a week later the collagen plug had broke free and moved down to her knee. This put hr at great danger of losing her right. Surgery proceeded, ultimately saving her leg. Permanent damage has been caused and she no longer has feeling in her right leg. She has since had to retire. I have worked for more than thirteen years in a cath lab and have first Hand experience that every pt has a right of the risks and benefits of every procedure so an informed decision can be made rs and I have many true stories that have brought on by cost. Most are issued by cost. Pts are dcd as as possible. also seen devastating perclose coincident causing death in a patient with normal cat,, to the heart die due to in due to per
Hoover, Rynand Heights, Kentucky, USA, September 18, 2010

To Clark, I am happy that the Mynx Vascular Closure Device worked for you, and hopefully for thousands of others. My case was radically different (see 10/16/09, 12/7/09, and 4/30/10). Its now 11 months and I have still have some visual and physical issues. Luckily, I am somewhat athletic, and I think this makes the outcome a little easier..but I still have some discomfort..I'm probably at 90% and I am sure at this point, 11 months later, that's about as good as I am going to do. Just recently checked with my urologist and he agreed.
Lewis, New Jersey, USA, September 14, 2010

• Hi all, I have just had an AngioSeal 3 weeks ago and I want to know what are the effects with day to day living. Not any information forthcoming from the hospital except to carry this card with me for 90 days.If I have an accident they are not going to go through my bag first so I am carrying a hand made card in my bra. Only thing so far is a funny feeling in my R/Leg sometimes, but no coldness. Any information is gratefully received. Thanks so much.
Fairy Blue Wren, Human Race Member, Australia, August 24, 2010

• My 81 y/o healthy Mom had an angiogram 7/12/10, and had immediate cold and painful leg. Was first told it would get "better" and would "dissolve" (yeah, walk it off~). Weeks later she showed me a card she was "given" talking about "her" angio-seal. The only "care" she was given from numerous complaints was strong pain pills, weeks 2 thru 4~! Finally a "specialist" she initiated contact with ultrasounded my Mom's leg on August 13th, and he was shocked to find it so blocked, and that Mom had had to put up with such pain and poor responses to her month of prior initiations and complaints to her original Angiogram Doctor. He scheduled immediate surgery for "removal" 8/16, with success.. but what a mess in Time PAIN Frustration LIFE. The leg is Still in pain but we hope a good-pain as it is "red" and we hope "healing & recovering" from a month of nearly no blood! Thanks Angio-Seal or its Inserter person~~~. For me now (and any I tell), I will request to lay around for a few hours and skip the gadgets!!!! For those with issues, my heart goes out~ get a clear 30 minute ultrasound and a Dr who is willing to address someone else's mess up. (saying it is in your head is just CRUEL~!.. horrible)
Kevin in OC California, Huntington Beach, California, August 18, 2010

• If you go into the cath lab again for another procedure, ask them to seal you with a "MYNX" closure device. This device is superior! There is no pain associated with the deployment. It is not made of animal product, like angioseal. It will dissolve in 30 days leaving nothing behind in your groin area to aggravate the site. You won't have additional scar tissue and you won't have pain for years to come! I had this device here in Philadelphia, PA. 1 yr ago. I had no issues, no pain, no complaints! I am allergic to certain foods and metals. If I had a an Angioseal I would have had an allergic reaction, if I had starclose I would have as well. Report all your complications to the FDA!
Clark , Philadelphia, Pennsylvania, USA, August 18, 2010

• Depressed in Orange County -- You'll find a number of other similar posts in the related topic, "Complications from Femoral Site During Catheterization, Angiogram or Angioplasty". Without further investigation, it's not possible to say if the Starclose device is in fact the problem. You may be suffering a complication resulting from trauma to the femoral nerve, which can occur during the procedure, and may have nothing to do with whether or not a vascular closure device, such as the Starclose, is used. Collected data shows that femoral nerve trauma/damage is an infrequent complication of femoral catheter-based procedures -- however, our Forum has many posts about this issue. Have you reported your problems to the interventional cardiologist who did your procedure? Perhaps a referral to a neurologist might help. Diagnosing the cause of your pain and numbness might point a way to treatment.
Angioplasty.Org Staff, Angioplasty.Org, August 9, 2010

• Starclose 4-24-10 pain every since numbness tingling all over right leg, tired feeling, heaviness, lower back pain i was in a wheel chair for 2-weeks or more problem walking sitting for long periods of time. Dragging my foot by the end of the day. have had no problems until that device was put in me. that device may help with recovery but the lifetime you have left is in pain. that device needs to be off the market until long term studies are done.
depressed and unhappy, Orange County, California, USA, August 9, 2010

• I had a heart cath done on 7-21-10 and basically have had no complications. I do have a small lump under the Angio seal site and it is tender but I'm chalking it up to being so new. I have to go see my doctor in the next week or two and will ask him about it if it is still tender.My doctor had me come in a week before the surgery and the nurse went over everything that they were going to do to me in detail and answered all of my questions thoroughly.It is a shame that not all doctors do this. I was upset that I had to take time off and go in for it but now am glad I did.My heart center is fantastic and so was the hospital. I can only say that if they are going to do a procedure on you and you know in advance...ASK QUESTIONS! They WORK FOR YOU! I feel much better since I had my heart cath and am glad I had it done.It's a shame that not everyone has a happy outcome. I wanted to give some of you a positive side to the procedure and Angio seal. So far so good.
Happy in Jax, Jacksonville, Florida, USA, August 4, 2010

• I had an angioseal inserted in 2008. Since I have had enormous amount of pain and swelling in my right thigh agets bind groin area. My thigh is swelling more and more each day and the dr is telling me it is unlikely to be happening from the procedure. It was recommended that I see a psychiatrist. I didn't because the pain along with the swelling is not my imagination. I am angry because I have been living with this pain for a few years now and I am afraid that the longer someone waits to correctly diagnose what is wrong the shorter my life span will be. I am at my wits end and don't know what to do. The pain is constant, the swelling ongoing and my ability to walk has been affected greatly. I NEED HELP ------- IMMEDIATELY!
Groin Pan in Delaware, Newark, Delaware, USA, July 26, 2010

• Michelle-Indiana and Concerned Patient from Pennsylvania -- you've both posted to the topic on "Vascular Closure Devices". It's not clear from your posts that your problems are from a closure device or even which device you got. Check out the topic, "Complications from Femoral Site During Catheterization, Angiogram or Angioplasty" and maybe post to that one. Also can you give the Forum a little more detail? And to Sara in Finland -- have you reported your symptoms to the cardiologist who did the angiogram?? You should, so he/she knows about it for other patients -- also you might get some specific assistance from someone who IS familiar with the StarClose clip. Thanks to all for posting!
Angioplasty.Org Staff, Angioplasty.Org, July 21, 2010

• i had a heart cath 4/16/2010 and i still am having problems swelling blood clot it is sad that i got pressured into this procedure by a doctor and now i am suffering its been 4 months
michelle-indiana, Genteryville, Indiana, USA, July 21, 2010

• I'm a 39-year-old woman who had catheter angiography to rule out an AVM on April 28. The femoral puncture was closed with a StarClose device. Everything was fine (no AVM, the puncture healed cleanly) but the soreness and pain that was supposed to pass in a week still hasn't gone away. I can feel the device (but there's no significant bump or swelling, nor has there been). An ultrasound scan was done two weeks ago, but everything "seemed normal" (but the MD who did the scan it had never heard of StarClose devices before). Sitting or doing (or wearing) anything that puts pressure on my groin makes things worse, so I take painkillers daily. Any advice or tips on how to make things better and hopefully be able to live without medication again?
Sara, Southern Finland, Europe, July 13, 2010

• Had a heart cath done about 2 yrs. ago. Couldn't walk more than 3 steps without falling for 3 days. Could not turn my right foot at all without severe pain. Immediately started gaining weight also 1st week I had the cath done. Still have pain in right groin area travels into the lower part of my back, still fall at times now, legs & feet are always swollen, pain in stomach. If pain is severe enough at times I can not lift my legs to walk have to slowly slide my feet along to get around. Nothing was explained or was I told anything would be inserted into the groin area. I also have numerous allergies to meds, latex, metals, & other things. What would cause all the swelling, weight gain, pain, & lack of mobility?
Concerned patient, Duncansville, Pennsylvania, USA, July 11, 2010

@ frustrated in Michigan post 6/19. Among other things...Ditto, strange things, almost exactly as you describe. Cardiac cath on 5/10, 3 stents in on 5/11. Very upset about the whole thing, and do not trust anything that was done. (I have a lump 2 inches below site, was told cyst, unrelated, don't worry. we'll see) Thanks for any updates or info you find out. I'll do the same.
uneasy, Highlands, New Jersey, USA, July 7, 2010

• Anniegurl -- have you discussed the possibility of doing the procedure through the wrist artery (a.k.a. transradial) with your cardiologist? You can find out more in our Transradial Access Center.
Angioplasty.Org Staff, Angioplasty.Org, June 29, 2010

• I had 2 stents inserted 7 weeks ago with manual compression...2 hours before sheath removal then 6 hours bed rest. I am having another stent inserted in 2 days and I am considering angio seal. The idea of 8 hours on my back, using a bed pan makes me want to go the angio seal route...any opinions?
Anniegurl, Sunrise, Florida, USA, June 29, 2010

• Getting heartwise -- the angio-plug is most likely what the techs call the Angio-seal -- there are other "plug" type closure devices, but Angio-seal is the most widely used. The most important thing is not to exert yourself too much for a short while, until the angioseal has set. The seal is made of collagen, which biodegrades after a few months. Not sure which model was used, but here's some info on the device, which is made by St. Jude Medical.
Angioplasty.Org Staff, Angioplasty.Org, June 28, 2010

• Hi. Is an angio-plug the same as an angio-seal? I had an angio plug put in yesterday after a cardiac cath and a stent installation. All went well. Just wondering what the plug actually looks like. I know it seals the area at the artery where they placed the sheath to do the cath. Just don't know what is under this gauze pad and tape. Thanks.
Getting heartwise, Hamilton, New Jersey, USA, June 25, 2010

• LKcurious -- a small percentage of people may have a hypersensitive reaction to bovine collagen, which is what is used in vascular closure devices.
Angioplasty.Org Staff, Angioplasty.Org, June 25, 2010

• Help w/ Info Please! I had angio w/ collagen plug a week and a half ago. I don't have any heart, artery or health probs. I am a 40yr old, 140 pd woman. I have had 9 neck and back surg's and I have a pedicle screw pressing against and displacing my vert. artery. I was in the hospital for two hours after the procedure, then sent home. My right thigh, groin, and down my right leg were very painful and puncture site was swollen. No fever etc.... Then, three days ago, pain stopped, swelling reduced. It seemed good then after about 20 min. of walking around in the house and cooking dinner the puncture site swelled up like a golf ball and twitching of my thigh muscle was obvious. This has continued and doc says not to worry since I'm not showing signs of infection or bleeding. OK! But, why is it bruised, hard, swollen like a golf ball, and all of the above increases w/ activity? What could this be???? Any ideas or similar complaints. Thanks.
LKcurious, San Diego, California, USA, June 22, 2010

• I had a heart cath two weeks ago. The StarClose site is driving me crazy with I best can describe as "irritation" and itching. I can feel the little bump. Nobody told me that it contained nickel and I do have an allergy to nickel, i.e., cannot wear earrings with nickel in them. Now what do I do?
Gail, Washington State, USA, June 20, 2010

• I had a heart cath done on May 14,2010. I developed a 3 inch lump above the entry site.They did a doppler said no clot. I started getting pain in my right leg and behind my knee and tingling in my foot. At times my calf gets real tight feeling. I have been back to the Dr. every week since. The pain behind my knee is so bad I cannot stand for long periods of time. The tingling in my foot is still there on and off. I also get a cool feeling almost like something is running down my leg. My cardiologist and my family doctor is saying this is not from my heart cath. I am frustrated. I need answers.
frustrated, Michigan, USA, June 19, 2010

• Dear "Underreported Adverse Events" -- We beg to disagree regarding your statement about the negligence of the hospital staff in your reply to Jim M. Retroperitoneal hemorrhages can be tricky to diagnose -- and they are often unrelated to the vascular closure device. But certainly patients should be sent home with instructions about what to watch for regarding bleeding complications. The staff may have had no signal that there was a problem. However, since this patient was done as an outpatient cath, it might give pause to the growing trend of releasing patients the same day. We should also point out that this type of bleeding complication does not happen when the transradial (wrist) approach is used.

We agree, however, with "SayNoToClosureDevice Okay" that many of these adverse events are not reported by the doctor or hospital (in fact, they often are not aware of these events, since patients tend to go to their primary care physicians with their complaints -- or write into this Forum -- and the adverse event info never gets to the interventional cardiologist who did the procedure in the first place).
Angioplasty.Org Staff, Angioplasty.Org, June 18, 2010

• Review the July 5, 2009 post. I encourage everyone to report their issues to the FDA, and do not assume or believe that their doctor or hospital has reported this to the FDA.
SayNoToClosureDevice Okay, Winston Salem, North Carolina, USA, June 16, 2010

Jim M of 2009. Absolutely negligence on the part of the hospital staff. Other patients retro hemorrhages are detected and corrected. Death was avoidable. Watch the FDA website for announcement concerning Angio-Seal investigation which may appear in 2010 or early 2011.
Underreported Adverse Events, Winston Salem, North Carolina, USA, June 16, 2010

• As far as I can determine there is no attorney in Winston Salem named Marc Hepp.
Doubt it, Winston Salem, North Carolina, USA, June 16, 2010

• On April 21, 2010, I had a heart cath and after the procedure was finished my daughter handed me a card which the nurse had given to her to put into my wallet. I was never told of this device prior or asked for my permission. I have many allergies to many meds, foods, etc and I do wonder if any of this was even looked at prior to putting this angio seal in me. I do have a burning sensation sometimes, nothing I can do about it, but I do feel the doctor should have discussed this with me prior to the procedure.
Marie R., Michigan, USA, June 15, 2010

• My Angio-Seal was installed 3/31/10 and now two and a half months later I have begun having persistent groin pain at the site of the seal. My Cardiologist's PA says this is just scar tissue from the incision and will eventually go away. Should I be concerned?
WTC, Conroe, Texas, USA, June 14, 2010

• I had a heart cath done on May, 23, 10. I was not told until I was sent home that they used a angioseal. A few days later I started having calf, toe and hip pain. I finally got a vascular dr to look at it and he said they implanted the angioseal too deep into my femoral artery causing blood flow to be slow. He performed a angioplasty and pretty much said it was in my head and not to come back. to this day I am still having leg and toe pain and have severe itching and rash on my right groin. I have never experienced anything like this. Any advice? I'm ready to seek legal consultation
40 year old in pain, Rogersville, Tennessee, USA, June 13, 2010

• I had a heart cath 23 months ago. I was 35 at the time. The doc placed an angio seal in my right femoral artery for closure. I woke up complaining of my right foot numb and tingly I told the nurse and doc if i walked on my foot i would break it. an hour later i was being sent home with now a numb leg from the knee down, telling me it would go away. 6 hours later my leg was without blood flow, was white and the skin was drawn up. I went to the ER where they had to remove part of the artery. It took 5 months to heal the wound. I still suffer with major pain. With no help from Drs in pain relief. I just had another cath in the left to fix the right artery repair where the plastic collapsed from the first repair. I now have two swollen lymph nodes and pain on the left. They did not use an angio seal, but my leg does not hurt. I have had 3 atty's turn me down, because this was just a risk to the procedure. i will have to have surgeries for the rest of my life and my even lose my leg in my 50's because of the angio seal. my life has come to a stand still, i go to work and come home and sit because of the pain. I am grateful , but it is ironic, nothing was wrong with my heart.
HEA OKC, Oklahoma City, USA, June 11, 2010

• I had a cath today, and they used the angio-seal, I have no problems, and find that it'a a great device. It let me get back on my feet quicker. As others have posted, complications are rare, but that's all people talk about, so they don't hear the positives.
blueyedmedic, Edison, New Jersey, USA, June 7, 2010

• I found this site while researching the angio-seal for work as a nurse chart auditor. I'm disheartened to see so many people practicing medicine without a license & willing to believe the conspiracy theory related to health care. My 74 year old father refuses to see a doctor because "they're all crooked,in bed with insurance companies, after my money." Well, he smoked 3 packs of Camels a day for 50 years many of which were spent working in an enclosed office with others smoking. He had 30 years of very heavy alcohol use & has had meat & potatoes for every meal of his life - adding 3-5 eggs to breakfast. But he couldn't possibly have ANY cardiac or lung issues. Never mind that he gets short of breath from the bedroom to living room of a 1400 sq ft home, is gray & cannot bend over without blacking out. There's nothing wrong with him; in fact, he hasn't seen a doctor in 10 years! And look at the money he's kept out of "their" hands. He'll be dead soon. I've accepted that.What I can't accept is that people would rather find someone to blame than be part of the solution, feel better and LIVE! We're not all out to get you. Report your problems via the methods listed here. Get a referral. Heal. Move on.
Rhonda, R.N., Missouri, USA, June 7, 2010

• Dear Legal Nurse- We are not just "complaining" Most of us were NEVER asked if we wanted these devices implanted. I did not know that I had the first one until it was already INSIDE me and the Dr gave me the card and it was THEN I was able to ask about complications etc. I was also never asked the second time was one implanted either. That is the problem! I'm glad I had my annie coiled, but wish I was allowed to make a decision on having the starclose placed inside my body as I was allowed to decide on my coiling. My cardiologists agrees with me too!
CM, New Hampshire, USA, June 4, 2010

• It has been over ten years since a perclose suture device was deployed incorrectly and I still suffer every day with ileohypogastric and inguinal nerve pain. I had it removed three years later, only to learn the damage was done...and no doctor knows how to help me. I have seen neurologists,etc... pain doctors,who put me on every narcotic...that still didn't help. I refuse all narcotics now. I was started on Lyrica which finally did help some...but I still am in so much pain! I need to find a physician to ablate these nerves, if it is possible. No neurologist in Pittsburgh has been found ,so I have calls into Cleveland Clinic now. If anyone can help me find a specialist for this I would greatly appreciate it. I try to be very active as I was before this nightmare began..and can't!!! And they still keep shoving these into patients to save time and money.... but look how many have been hurt or even killed!!!!!
Donna R.N., C.D. Ladani cardiology associates, Grove City, Pennsylvania, USA , May 31, 2010

• I had a vascular closure system placed by my cardiologist last September after a heart cath was performed. Two months ago I started experiencing severe pain on my right hip traveling all the way down to my leg. I am also experiencing charley horse pains like never before. The groin area where the Perclose was placed is tender to the touch and even lying down I feel like someone is pricking me with a needle or knife. Do not allow yourself to have this device placed in you.
Blanche, McAllen, Texas, USA, May 30, 2010

• In response to Legal Nurse, yes, there are risks to everything. But the medical community owes it to each patient to see that INFORMED consent is given for procedures. Many patients are not educated on options or complications prior to invasive procedures. I myself have a Starclose which is made of titanium nickel alloy, but no one asked if I had a metal allergy prior to its insertion, however, each new staff member asked for my birthday when they entered my room. It seems THEY didn't want to assume any risk, which every non-rocket scientist knows is part of life. The 2 staff members that I did inform of my allergy to base metals didn't seem to think it important enough to mention in my paperwork. People should not have invasive procedures without the education and information they need to make decisions that could affect their quality of health and life post-procedure. That is the role of the staff of doctor's offices and hospitals to provide not only the means to remedy but the information to make the decisions necessary to remedy in full disclosure prior to surgery, not in a pamphlet handed to you post-procedure.The kicker for me? My stress test was false +.
Just Another Guinea Pig, Carmichaels, Pennsylvania, USA, May 28, 2010

• Procedure 5/4/2010... right leg, Female, 51 yoa. My RIGHT upper thigh and knee, and foot has a feeling of numbness, The feeling is not unlike that of when the foot has is "aleep" , but no tingling, just numbness, and the foot has intermittent pain. just want to feel normal, it's been two weeks, but will this ever go away????? How soon can I resume walking/ running/ wear 4" heels????? I'm almost sorry I had the procedure!!!
Dee, El Paso, Texas, USA, May 18, 2010

• OK everyone.... there are ALWAYS risks to ANY invasive procedure no matter what it is. It does not take a rocket scientist to figure that out. Additionally, you can ASK questions before any procedure is done and ask what the risk & complications are. Stop the deflamation. The procedure that you are referring to most likely gave you or your loved one more years added to your lives. Get a second opinion if needed, then drop it. Enjoy the EXTRA time you have to LIVE.
Legal Nurse Consultant, Wichita, Kansas, USA, May 17, 2010

• My body rejected the Mynx Vascular closure device. I had a heart cath two weeks ago and began to develop a lump at the site of insertion almost immediately. Three days after the cath I was in another state for a family emergency. The lump became unbearably sore,swollen, red and within five days looked like a boil. The first Urgent care dr wouldn't touch it but after conferring with the cardiologist gave me massive doses of antibiotics in shot and pill form. The next day the site was worse. A different dr at the same urgent care lanced the site, sent a sample to the lab, and removed the Mynx. Days later the report came back that my body had rejected the device. What would have happened if it were left in????? My 14 day antibiotic routine of six pills a day is kicking my butt and making me ill with diarrhea. When will this stop?????
PG, Cleveland, Ohio, USA, May 16, 2010

• Wanda H. -- Don't panic. Angio-Seal is the most widely used femoral vascular closure device. What you read on our Forums are all the complications. Unfortunately the vast majority of patients who have had caths or angioplasties and who have had no complications from Angio-Seal (and that would be 94-97% of patients) seldom post here. So you're reading a distillation of the worst stories -- helpful to patients who have had problems and are looking for support -- but only anxiety-producing for people who are concerned but who have not had anything go wrong. One of the issues we feel is that most patient consent forms are blanket in nature -- and each device used is not subject to a separate consent. (That's our understanding. If any healthcare professional out there knows differently, please post.) In any case, many patients have posted that such a device was used without their consent -- that's not technically correct, but the impression only breeds mistrust.
Angioplasty.Org Staff, Angioplasty.Org, May 3, 2010

• HELP my husband had the ANGIO-SEAL put in this morning{04-03-2010} with out us knowing!!!!! I hope he is going to be ok??? someone please put something good.
Wanda H., Georgia, USA, May 3, 2010

• To Nancy Holland and Rocky can see my posts regarding the Mynx Vascular Closure Device below (10/16/2009 and 12/7/2009). Even today, 6 months later, I'm not fully recovered. The scrotal hematoma generally healed, but not fully, as there is still discoloration and some discomfort from absorption or blood clots eventually dispersing into other areas of my genitals. During my last visit to both my urologist and cardiologist about 6 weeks ago, they both said that this is a normal result, and it will get better, but honestly 6 weeks later, it looks the same. The cardiologist mentioned again that this was the first and last time he (and I believe his team) will ever use the Mynx Vascular Closure Device...he has not used it since.
Lew, New Jersey, USA, April 30, 2010

• I too had a Star Close device after a angio-catherization back Sept. 09. I forgot about it until I changed wallets and found the Star Closure card in my wallet. This was also inserted without my permission. The card was given while still groggy and I never gave it another thought until now. I have been having intermittent pain in the same area as the Closure. I have been thinking its my appendix. I also just finished a cross Country trip and had total hip pain several days on our vacation. Should I let my Cardiologist know about this now or wait for my appointment with him in August 2010?
Peggy Su, retired, Port Orange, Florida, USA, April 26, 2010

• I recently had a Star Close clip placed. The brochure I was given to me to carry around states "The Star Close Clip" is MRI compatible. I too was not asked my consent about receiving this device and I am concerned about any future issues that it may cause. I would have preferred to have been given a choice.
Deborah C, Springfield, Tennessee, USA, April 24, 2010

• I had a mynx vascular closure device on the 6th of april and today is the 21. I am in agonizing pain and I am trying to find an answer before I go to the hospital
Nancy Holland, Magnolia, Mississippi, USA, April 22, 2010

• I am a 43 year old active female who underwent a Heart Cath 3/6/2010. I was not informed that the Angio seal was being used either. Cath was clear, no blockages, but 10 hours after the cath , I started having numbness and tingling in R leg and the leg started turning purple (still impatient) I called for the nurses and was told they called the Dr. and i would have an ultrasound the next morning. The next morning had the ultrasound and was Dx. of having a blood clot at the site of insertion. I was convinced this was caused from the cath. I still have pain at the site and a lump remains there. I was put on blood thinners and have to give myself injections of lovenox twice a day. This will go on for 3 months i was told. I also had an appt. with the Hematologist 1 month later and he informed me that he had a cath a week later and developed a hematoma at the site. He and the Cardiologist are friends so i was amazed he told me this info... but he said the Cardiologist was going to report this to the manufacture of the angio seal. In the mean time i will report this to my Lawyer... Thanks for the site...
Kathy Begue, Fort Campbell, Kentucky, USA, April 20, 2010

• We're not sure how we feel about posts like the one below from a lawyer obviously trying to get clients for a law suit. We would like to hear opinions from readers if this type of posting is of any value. As for under-reporting adverse events, patients can report an adverse event from any device directly to the FDA -- But we agree that all adverse events of vascular closure devices and access site complications in general are under-reported (most cardiologists we've discussed this with agree). In fact, the American College of Cardiology did a study from the NCDR database a few years back and showed that VasoSeal, the first vascular closure device marketed in the U.S., had far more complications than its competitors -- and this resulted in VasoSeal being taken off the market. The reason vascular closure devices were invented is to help patients ambulate (walk) sooner, as well as make the procedure quicker. But they add costs to the procedure (a few hundred dollars) rather than lower them.
Angioplasty.Org Staff, Angioplasty.Org, April 20, 2010

• I'm an atty- I believe post-Perclose complications are being under-reported and mis-reported to the FDA and uninvestigated by Abbott Vascular. These devices had one purpose only- quicker hemostasis means less costs and more patients per hour. Almost all of the studies done have been conducted by research organizations who are dependent on Abbott, and don't have any relevancy to what's happening in every-day cath-labs. I've caught a whole batch of people dirty as hell on a procedure, and when I studied the MAUDE reports it's clear they're for compliance- not safety. Does this sound familiar- "Although requested, no additional information was available."? It should. It's contained in 95% of Abbott's required reports over the last four years. Write me if you're out there- Marc
marc, Winston Salem, North Carolina, USA, April 20, 2010

• i for one had the angioplug inserted after 2 stents in 07-08,i couldnt walk more than 100 steps without stopping to rest, blood flow was restricted, i searched for 6 months to find a vascular surgeon to undo this mess, found a doc at columbia hospital in nyc,, wow i am fine now thanks to Nicholas Morrissey, M.D. I owe u sir.
Mike Eisner, New York, USA, April 3, 2010

• I am a 53 male, i had a cath done on march 4, 2010. they used the mynx closure. the next day i developed a lump right above the entry site near the groin. i had 2 dopplers and they said everything is fine. i had to stay in the hospital for 2 days because the vascular surgeon made an incision on the lump. it drained so slightly. they didn't say it was a hematoma either. over 3 weeks later and I'm still on antibiotics, now they are telling me that its probably from the mynx. did anyone else have this kind a reaction to the mynx. i might have to have more surgery. or is this dr error!!!!
Rocky A, Bayville, New York, USA, March 27, 2010

• I had a heart cath done on January 26, 2010. I went for a routine heart assessment test done by the hospital. I ended up in the heart cath lab where I was given a heart cath. I was told everything was fine. I was not awake during the procedure. When I left for home they handed me a pamphlet telling me about the Angio-Seal they had used. After a week of being home with not being able to walk because of the pain I called the cardiologist about how bad my hip and thigh and leg hurt. She had me come in. She sent me to the emergency room for an ultra sound to see if I had a blood clot. There was no clot. They did say I had swollen lymph nodes. I went back a week later to the cardiologist and they told me they thought it was the sciatic nerve. It hurts really bad when I get up from a sitting position. Its hurts clear down my leg into my foot. Don't know if its the Seal or what. I need to get some answers. Its been almost a month. Wished I had been informed about the Angio-Seal before instead of after.
Sandy H, Kalamazoo, Michigan, USA, March 25, 2010

• I had a cardiac ablation to my heart on 7/10/2010, and the site of where they went in and placed the two Angio-Seals was tender for three months, it is now 3/19/10 and in the last week, I have an incredible amount of pain radiating from the site. I kept wondering, what could this be from until it dawned on me that this is from the entry site from the ablation and where the Angio-Seals where placed. Came into work this morning to do research and much to my surprise, others are having the same problem, pain radiating and shooting down my leg and to my upper hip. Please, anyone who is finds they are having this too after months of having the surgery, email me @ (Monique). This is really painful, feels like a nerve is causing the issue from the vascular seal. I was "NOT" told they were using this, or given any options at all. I didn't even know how they closed the entry site, until I found weeks later in my bag that I brought in to the hospital the Angio-Seal card and brochure that I had to carry with me for ninety days. The nurse slipped it into the zipper section on the inside of my bag. Thank God I eventually checked the bag or I would have never known. Crazy!!
Monique Joyner, New Orleans, Louisiana, USA, March 19, 2010

• re: Tammy - "if there are no negative consequences to the doctors or hospitals, where is their incentive to get it right the first time?" what kind of nasty comment is that? it's unfortunate your husband suffered a complication from a procedure that was done to save his life, but doctors are not routinely in the habit of doing things carelessly so that people come back to the hospital with complications. that is the very last thing we want. do you think we enjoy taking care of disgruntled patients who want us to suffer negative consequences? i mean, really - that's incentive enough!
WI, Minneapolis, Minnesota, USA, March 13, 2010

• Concerned Wife -- you posted under the "Vascular Closure Device" topic -- did your husband have one of these? Because there is also a topic on "Complications from Femoral Site Catheterization" -- and it may be more appropriate, although they are related. A number of patients report that this immediate pain and problems in the leg do go away in a few days or so -- of course, some complications last longer. Have you discussed this with the cardiologist who did the angiogram. If for no other reason, he/she should be aware of the complication. Another reason we have been writing about CT Angiograms as a possible alternative to nuclear stress tests or to invasive angiography in patients at intermediate risk or who have no symptoms but do have a positive nuclear stress test
Angioplasty.Org Staff, Angioplasty.Org, March 14, 2010

• My husband had this procedure done just a few days ago. He also was not informed until he was being discharged. I've searched since on recovery time. He has trouble walking and pain. He had a nuclear stress test done and was told there might be some blockage. This test came back clear. We tried to tell the dr. no but he pressured him into it. Now my husband will more than likely not be able to return to work. I feel that some drs. need to be held accountable for not informing patients of the serious of this. It took away my husband's livelihood. And if it doesn't absorb then what will it do? Our personal phys. wants the same answers. No one informed us nor did they give any options-such as the arm. Right now I feel he's looking at a long road to recovery. The dr. that did the procedure didn't even come back in to check on him. I don't know much about today's drs. but it makes me wonder if this is why health care is such an important issue today. And how many people have to be put through this kind of mishaps before they get it right.
concerned wife, none, Fort Worth, Texas, USA, March 13, 2010

• Hi, I was in the cath lab on Aug 21, 2009 and i had a mynx put in. they got me up to walk before i went home and i had the worst pain in my ankle, so they hauled me down to cath lab did another test and found the closure had went into my veins. it disintegrated. i was taken in for emergency surgery. they got some of it out but had to call the manufacturer to see how to get it out. well on Aug 23rd i had to go back for another emergency surgery to get some more out. i was in the hospital for 7 days and at home for 3 1/2 months with a home nurse coming every day. i had 3 or 4 infections in one of the cuts, which by the way are about 4 inches long each one. well today is mar 9th, 2010 and guess what. went to cath lab again and had 3 more veins done because the gunk from the mynx was in them. i have been laid up for months now and it has not been fun.
Roberta Lynn Henry, patient, Michigan, USA, March 10, 2010

• On Friday 26 February 2010 I had a cardiac catheterization at St. Lukes, in Milwaukee, WI. The procedure went off without a hitch, I did not experience pain in fact very little discomfort. The test result showed that I had no blockages in my heart nor did I require a single stent. We were literally done in five minutes… The doctor then applied the Mynx wound closure system to the needle insertion site. Result immediate PAIN; so much so that my breath was reduced to gasps between clenched teeth while on the procedure table. (Hurt like a %!#*)I requested pain medication and since the procedure, the discomfort is not getting any better. 1. Pain in lower abdomen, 2. Swelling of my entire right thigh leg and lower right torso. 3. EXTREME TENDERNESS in my groin, (did I emphasize extreme?) 4. I cannot sleep on either side or even urinate without discomfort. I have been off from work for an entire week (so much for the in by 06:00 out by 12:00 noon argument). Today is Tuesday 9 March and I’m still off work and sore as hell.
Bruce, Kenosha, Wisconsin, USA, March 9, 2010

• I had a heart cath. done 3 days ago. They used the angio seal to close. My potassium was low. I was given 4 bags of potassium before being sent home. The next morning I had severe pain at the groin site and down my leg. I had pain down the middle of my leg the next day. Tomorrow I go back to work at a very large hub. I am afraid I may end up in pain or pass out. The doctor said to give it 72 hours. I wish I had been given some info on this. Thanks.
Robin H., Louisville, Kentucky, USA, March 1, 2010

• Tammy from Ohio -- Vascular Closure Devices were developed to reduce complications from bleeding and to allow patients to walk sooner. They have done that, but they carry with them their own brand of complication -- small in percentage, but not if it happens to you. Consumers can report an adverse event from any device directly to the FDA --
Angioplasty.Org Staff, Angioplasty.Org, February 8, 2010

• My husband had a stent procedure done in November. He ended up with 4 drug coated stents. He is 47 years old and has bad family history, but otherwise in excellent health, active, eats well, and not overweight. We had one complication after another after the initial procedure. In short, the closure device used was blocking blood flow to his leg. This time he had to have a bypass to remove the closure device and a good portion of his artery as well because it was becoming diseased. Since this procedure in December his scar is still bothering him and the nerve damage is expected to continue bothering him for up to another 18 months! Why are these closure devices used if they cause such complications? Furthermore, if there are no negative consequences to the doctors or hospitals for complications where is their incentive to get it right the first time???
Tammy, Ohio, USA, February 8, 2010

• Karen from Michigan -- as you can read here, and counter to what you've been told, there ARE complaints (with over 500 postings, this Forum Topic is unfortunately one of the most popular on our site). Granted -- in percentage these complication are small -- most studies have shown complications in about 3-6% of catheter-based procedures done from the femoral artery. Are they under-reported? Some cardiologists think so. For example, do you think your experience has been reported as a complication? But don't be afraid for the next time. Discuss your experience with the cardiologist doing the procedure. Also look into getting the procedure done radially next time. There are an increasing number of cardiologists who use the radial artery in the wrist to do angiograms and angioplasty (check out our Radial Access Center). The advantage is much fewer complications, especially in overweight patients -- but only 5% of procedures in the U.S. are done this way because it's a relatively new approach and most cardiologists were not exposed to it in their training. And there is no need for a vascular closure device -- only a pressure dressing.
Angioplasty.Org Staff, Angioplasty.Org, February 4, 2010

• I had a heart cath done in Sept 08. I was immediately diagnosed with 2 blockages in my heart @ 95%, sent by ambulance to a larger facility to have angioplasty done, and after which they used a star close on my right femoral artery. I am over weight but never had any previous complications with the inner thigh (groin) area. I have more days than not with pain and at times it's hard to walk (maneuver) my right leg and hip. I have mentioned this to my cardiologist several times and he states he has heard no complaints. This is very disappointing and I am not sure where to go to find the answers. I am tired of living in pain and I have recently begun to have more symptoms of another blockage but out of fear of the heart cath and more angioplasty with the possibility of another problem like this one scares me to death.
Karen, heart patient, Michigan, USA, February 2, 2010

• On May 29th 2009 i had Star Close inserted in right groin, have been suffering since. having nerve damage checked soon. I too have most of those symptoms, very painful always, getting up from a sitting position,up and down stairs. So exhausted.
Doris F., California, USA, February 1, 2010

• Shelly from West Virginia -- one of the questions is whether or not these adverse effects are caused by the closure device (Angioseal, Starclose, etc.) or by a problem in the catheter insertion needle stick. There is also a Forum Topic on "Complications After Angiography" in which you can read many of the same complaints -- even when no closure device is used.
Angioplasty.Org Staff, Angioplasty.Org, January 29, 2010

• I had an angio seal used on me after heart catheterization on 10-05 05 ,i have the same problems with my leg going numb back hurts groin pain stomach pain .pain while walking foot goes numb leg pain. I had angioplasty done still the same her it is 2010. need to find out if any class action suits being filed for angio-seal st. Jude they need to stop using these seals on people and also get permission also to put in your body. I also have a hernia at the site.
Shelly, West Virginia, USA, January 28, 2010

• Angioseal uses bovine collagen. As to when you can work out, you should consult your cardiologist.
Angioplasty.Org Staff, Angioplasty.Org, January 28, 2010

• I had the angioseal placed on Jan. 11, 2010. No complications, but I'd like to know how long I should wait before I can workout. Also, I had collagen injected into my lips 10 years ago and it turned into hard balls of mass, instead of smooth lines. Is it the same type of collagen they use for the Angio Seal? If so, should I be worried.
Mari, Iowa, USA, January 27, 2010

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