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Angio-Seal, StarClose and Vascular Access and Closure Devices (2007 archive)
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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. • 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. • 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? • 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! • 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? • 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.) • 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. • 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! • 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. • 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. • 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. • 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. • 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. • 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. • When was the Starclose introduced? and how
much training do the Cardiac Surgeons receive before they use it? just
wondering. • 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)? • 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, • 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 • 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! • 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 • 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. • 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. • 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? • 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. • 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 • 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? • 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. • 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????? • 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 • 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. • 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? • 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. • 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? • 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. • 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. • 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. • 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. • 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. • 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? • 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. • 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. • Deborah -- there are many papers written on
potential complications from vascular closure devices. There is also,
of course, this Forum Topic. • 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? • 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.
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?? • 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. • 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. • 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. • 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! • 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. • 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. • 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!!!!!!!!!!!!!!!!! • 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. • 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. • 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. • 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! • 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. • 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! • 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. • 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. • 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. • 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?????? • 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 • 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. • 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. • 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". • 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. • 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. • 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. • 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? • 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. • 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. • 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? • 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. • 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. • 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? • 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. • 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? • 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. • 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. • 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. • in terms of medclose device, does anyone know
where this device is undergoing clinical trials? • 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)? • 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. • 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.) • 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. • 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??? • 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? • I urge everyone to fill a report out on Med
Watch who has had problems with the Star Close. I did so this
morning. • Leslie in Pennsylvania, please contact
me. I would love to pursue this. Thanks. • 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. • 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? • 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?? • 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.]. • 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. • 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. • 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? • 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). • 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. • 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 -- 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. • 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. • 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. • 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. • 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? • 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. • 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. • 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. • 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? • 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. • 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 • 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? • 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? • 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:
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. • 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. • 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. • 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? • April, the "Instructions for Use" (a PDF is posted on the FDA site) for the StarClose read:
Angioplasty.Org Staff, Angioplasty.Org, January 1, 2007 |
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