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Angio-Seal, StarClose and Vascular Access and Closure Devices (2009 archive)
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Archived Postings from 2009 on This Page (90): • I had an diagnostic angiogram in Sept. 2008
and had a StarClose used to seal the femoral artery. Since then I have
had frequent pain in that leg, starting from the site of the incision
and radiating downwards. About 10 days ago the pain become much worse
and is almost constant now. The area around the incision site is tender
and the skin over it is very sensitive. I was diagnosed with Fibromyalgia
in Sept. and don't know if that could be related to it somehow? It
is flaring right now, but the leg pain started before the flare. Still
worried that it has something to do with the StarClose. • I'd like to give an
update to my post on October
16 regarding the Mynx Vascular Closure Device. So I was officially
diagnosed with a scrotal (testicular) hematoma. My cardiologist (and
I believe his team) will not use this device again. I am under the
watch of my urologist. Anyway, its nearly two months and things are
getting better..but the healing process is slow. I'm probably at 85%.
The discoloration is gone and the scrotal area is looking reasonably
normal. The left side is nearly fine and the right side appears to
still have blood that needs to be absorbed (my radiologist confirmed
this). I have a visit with the urologist tomorrow and he will determine
whether I should just give it more time to heal or whether a procedure
such as a hydrocele would be needed. The biggest problem is that you
are supposed to be exercising right after this surgery, but I was in
bed for 10 days, out of work for 17 days, and overall, the first month
was focused on just being able to walk without pain. I am now working
out, and I'm hoping that be the end of the year, I will be "normal". • Tom -- The official FDA-required package insert
for the StarClose states, "The safety of re-puncture at any time
through any part of a previously deployed StarClose Clip, and the safety
of subsequent closure of this re-puncture using the StarClose Vascular
Closure System, have not been fully established." That being said,
many cardiologists successfully re-enter the clip or re-puncture the
artery, and there are a number of papers out there with details on
these techniques. Since, like you, most patients who get an angiogram
are likely to get another, a device that rendered the artery unusable
for future procedures would not be very marketable. As for removing
the StarClose, this can only be done surgically. But if it's not causing
a problem, there's no reason to. • Please tell me that the StarClose device can
be removed. I had one used on my femoral artery about 6 weeks ago.
If I had known that it would be used, I would not let the doctor work
on me. For the past 7 years, I've had either a stent or angiogram every
6 months and I need that access in my right femoral. The left femoral
is 70% blocked so it can't be used and I'm not sure if the wrist or
elbow can be used for the larger cath procedures, like my carotids.
Right now, I would feel a lot more comfortable with future procedures
if the thing can be removed. • Jim -- Terrible tragedy and our sympathies
go out to your and yours. A retroperitoneal hemorrhage is one of the
most serious complications of a femoral artery puncture -- sometimes
difficult to see because the blood fills the retroperitoneal cavity
(which is quite large) and is not obvious until it has become a very
serious problem. One question: was it documented that the cause of
the hemorrhage was a failure of the Angioseal? The reason we ask is
that the AngioSeal is on the front side of the artery and bleeding
there, caused by a rupture, would be more obvious and sooner. What
happens in a retroperitoneal hemorrhage is that when the access needle
goes into the artery, it goes too far and it goes out the back wall,
causing a backward bleed. Vascular closure devices only seal the front
end and a puncture in the back is hard to diagnose. These complications,
while relatively rare, are very serious and is one of the reasons we
at Angioplasty.Org have been promoting greater use of the radial (wrist)
approach, where none of these issues exist. Let us know any more details
and, again, please accept our sympathies in the loss of your loved
one. • My husband had
a right lower extremity revascularization of the right superficial
artery on Aug 7, 2009. They placed an Angio-Seal vascular closure in
the left femoral artery. This was an outpatient elective procedure,
in at 8 out by 2. Sometime during the middle of the night the seal
failed producing a massive retroperitoneal hemorrhage. Blood filled
the body cavities, could not breath and suffocated. He was dead less
than 20 hours after the procedure. Has anyone had any success with
St Jude on failed seals resulting in death. Any recommendations? • On Feb. 25, 2009 I had a Perclose device inserted
following stent placement and angioplasty. Within thirty hours I was
found to have a 50% loss of blood flow to my right leg which necessitated
emergency surgery to revascularize the femoral artery with harvest
of saphenous vein. Needless to say I am now very concerned to ever
have that procedure done again. • Update to previous
post -- I saw a vascular surgeon he advised me not to get another
closer [StarClose] device, he stated they are not needed. Had ultrasound
of thigh, both star closer's seem to be properly placed. Surgeon
feels the pain, swelling and numbness may be due to scar tissue around
device. He said it CANNOT be removed, only bypassed which would mean
they would have to take an artery out of my leg and bypass the area
with the star close device. Seeing a neuro this week to evaluate
for nerve damage. PLEASE PLEASE Report your issues with this to the
FDA!! Using their adverse report online system ! it is confidential!! • Gale -- by "stent" in the way, do
you mean the StarClose device? It's not a stent, and it shouldn't cause
a problem with re-accessing the artery in the future. However, the
numbness you feel may be the result of nerve trauma from the needle
stick and catheter movement and may or may not be related to the vascular
closure device. Also read the related topic on "Complications
from Femoral Site During Catheterizations". • had carotid angiogram done October 2009, procedure
went fine, ending with insertion of Starclose. When attached severe
pain ran down leg to inside of right foot.[Twice] Tingled a lot and
leg felt numb entire time was in recovery area About 1 hour, reported
to doctor in procedure room and nurses in recovery area, no comment
from them. Still one month later I have a numb sensation, all the time
and a painful tingling at numerous times during the day and night,
on the inside of my right foot and ankle. The skin is so sensitive,
I cannot stand for the area to come in contact with even sheets on
the bed. There is no external sign of a problem. Will the stent be
in the way if you have to have another catheterization study? Will
the tingling and numbness go away? • T.J. -- Just so we're clear, the groin/leg
catheter access site is via the femoral artery -- right at the groin,
the crease where the thigh meets the lower torso. By "groin",
doctors don't mean the scrotum or area in-between the legs. But you
should know where the catheter went in, because you would have had
a bandage and some healing going on there. So technically, the access
site is the "groin at the top of the thigh". • I had a heart cath in sept 2009, around a
week or so later I developed sharp pains in my leg at the groin site.
In the next days to come I could feel the angio seal moving up and
down and clicking as well. It was and still is very painful. Since
then I 've went back to the same hospital. When I explained what was
going on about the clicking and moving as well as the sharp pangs that
I felt up and down my leg as well as the severe pain in my groin area
the doctors reply was" the doctor that did the cath did not go
in through the groin area, he went in through the thigh" he knew
as well as I did that he went in through my groin area. That's how
it was explained to me and that's the sight that they went in through.
Now I have been to two doctors and they are trying to tell me that
I don't feel what I said I do where I say that I do....but I have to
go and get another operation tomorrow which is november 4th 2009. I
just want to make people aware of some of the dangers of an angio seal.
Now they say that I have a hernia which I don't believe right at the
same site.also I caught pneumonia a couple days after the procedure.
I am in severe pain as I write this. People please be aware. • To all posters -- and we've written this before
-- although they were invented to reduce complications from bleeding
and to allow patients to ambulate (get up and walk) earlier, these
device come with their own set of complications. However, some of the
problems patients are posting here may be due problems with the catheterization
itself (the needle stick, puncture of the posterior wall of the artery,
resulting in a serious hematoma or bleeding complication, or trauma
to the femoral nerve -- something which might result from a closure
device, but more likely is from an off-the-mark needle stick or from
catheter manipulation. We suggest inquiring as much as possible from
your cardiologist. Also read the related topic on "Complications
from Femoral Site During Catheterizations". • I had a heart cath done in the right femoral
artery that was closed using the mynx closure device. First 2 days
were fine but day 3 developed swelling, pain, and bruising on the site
and especially in the groin area. I am a male so this made sitting,
walking, and going to the bathroom difficult and painful. Contacted
Dr.'s nurse ,she said this was normal as most people looked like they
had been hit with a baseball bat.Is this normal? I also contracted
a staff infection that was MRSA, spent a week in hospital for that
hooked to a wound vac for 2wks.It has been 8 wks since surgery for
infection (removed device while cleaning out wound)still have tenderness
in lower ab and groin area.If anyone has had similar pain from any
of these procedures or infections from using mynx or other devices
let me know. The VASC. SURGEON said the infection came from the closure
device. • ok as others I also had heart cath.only 4
days ago October 19,2009 and was given the Angio-seal with out any
information before hand. I woke up on the table with someone trying
to so something and 3 other attendants came over something was wrong.
A few hours after leaving the office immediately called dr complaining
about the pain in the groin area which goes around to the lower back
and numbness down right leg to foot. Unable to stand or sit and trouble
walking. The Doctor ordered the tests necessary to rule out blood clots,but
still have pain numbness . I went to my Chiropractor and got a little
relief but still unable to sit or stand with out the pain. Not sure
what to do next.No fever or bruising just the pressure. feels like
the angio-seal is pressing on my nerve.Very sick to my stomach all
the time.debi • I am 53 years old
and 4 days ago had an angiogram and as a result a stent placed in an
artery that was 95% closed. The stent procedure went well, but the
closure device has had serious and very painful results. My blood pressure
dropped that evening to 65/35 and soon I was wheeled down for an ultrasound
as my scrotum and lower body was turning black and blue. The device
used was called the Mynx Vascular Closure Device, which is a sealing
device. I was released from the hospital yesterday, and can not get
around at all. My groin is in tremendous pain and my scrotum and upper
thighs are significantly swollen, black and blue, etc. Because I am
athletic ( a former marathoner) and in good health, I was told that
I may have been the first person to use this particular closure hardware
at this hospital, which is a leading cardio hospital in the US. Luckily
I an able to urinate without difficulty. I have follow-up visits scheduled
with my internist, cardiologist, and urologist. I've been told that
the answer to my problem is time....does anyone out there have a similar
story and is there hope that I will get back to my former self? • I have had an angio seal 18 days ago i have
burning sensation in right groin calf aches like hell after two hundred
yards walking on the flat and much quicker on a slope foot felt like
it was on fire after playing tennis with very little running around
-- kerry 49 uk • My name is Anita. I had the catheterization
done in Dec.23 of 2008. here it is Oct. 14, 2009. I am in a lot of
pain, I have went back to the doctors many of times. and nothing is
being done. I have went the nerve doctor, and he found nothing wrong.
I've been put on pain meds, but they don't work. I have muscle spasms
and everything else that everyone is saying. I did not know that this
star close was a permanent thing. the doctor didn't tell me anything
about it. it is hard for me to do my job. its hard to walk. I was told
that I had a lymph nodes, and that it would go away. but the pain is
still there, and getting worse. I will be looking into a lawyer. and
if anyone else wants to join me, get in touch with me at anita.grant@comcast.net
-- it's time that something needs to be done about this. • I had a heart cath done on Aug 22, 09 and
i ended up with an 8 day hospitalization and as of this day still have
nurses coming to the home. i had the mynx closure device and which
i didn't know i was getting. it dissolved upon placement and went into
my veins in my leg. had 2 major surgeries on my leg and 3 heart caths.
i haven't done anything in 2 months and have had 2 infections for which
right now i am being treated for the second one. this has been horribly
painful, my leg has majors scars on it nd i have been all around miserable.
i was told after the fact that the odds of having this happen were
0.05%. has anyone else had this happen and what about suing. i was
also told the drs couldn't get the gunk out and called the manufacturer
and they gave them some ideas but didn't' have a protocol in place. • DF -- The StarClose is a permanent nitinol
clip and can only be removed surgically. • has any one found out if they can take out
that Star close? • I had catheterization done 3 weeks ago, no
blockage was found just a couple of leaky valves doc said not to worry
about. I have a angio seal in my right femoral groin area. three days
ago I started having pain on the inside of my right leg and now walk
with a limp, is this normal, will it go away in time. I am otherwise
a very healthy 57 year old women. • I had a UFE in October, 2008 and they use
a star closure on me without my permission. I am a registered nurse
and I would have much preferred to lie flat on my back for 6 hours
then to have endured the pain from just the insertion of the star closure.
First of all, being unaware the device was being inserted, it was more
painful then the entire UFE procedure. It has been a year, since the
procedure and I have had right leg/hip pain and numbness consistently,
especially, when I do certain exercises or sit for a while (like driving).
The patient needs to be given the option for a star closure and I was
not give the option. I am for sure I would not have chose this option.
I hope the device is being evaluated and patients are given the option
and know the risk and side effects. I pray my right leg doesn't get
any worse over the years. • I had stent implants in April 1998, July 1998
and August 2009. All three were by the same doctor. The first one was
done with the "angio-seal salesperson" in the operating room and worked
fine. The second and third angio-seal did not perform at all. A nurse
had to hold her finger in the"hole in the dike" for hours to stop the
bleeding and on the third one I got the sand bag treatment for the
night.With four by-passes and three stents since 1982 I think that
should I need another stent I will request that your sales person be
in attendance. Any chance of getting my money back on the two that
did not perform as advertised? • I just had my second angioplasty and stent
placement; the first time being in February 09. Stent and angio in
left leg, 2 angio balloons in the right leg. The right leg did not
fare well, so last Thursday (9/17) I had the left stent angio'd again,
and a new stent placed in the right. I feel great. I have posted here
before regarding the Starclose issue. This time, I was made to lie
flat for 12 hours - 6 hours after the angioplasty, direct pressure
on the groin was applied by the nurse for 20 straight minutes, and
then I lied flat again for 6 hours. Not fun, however, the incision
healed beautifully. As happened the first time, I have a rash in my
lower body and am wondering if it my body's way of reacting to the
stents? • I had the Starclose device implanted after
a heart cath.in 2006. I have had no complications. However I was 45
at the time with "wide open" veins. Now I have a piece of metal in
me for the rest of my life, put in without my knowledge or consent.
Now 3 years later I have autoimmune disease(s). IS THIS A COMMON OCCURANCE?
I have to have a MRI and they are hesitant to do one! What does this
say??? After surgery the hospital couldn't give me much information
on future problems, because we are the Guinea pigs. I was told to contact
Abbott Labs. How truthful are they going to be? On my paper I carry
around in my purse it doesn't give a number , how does Abbott Labs
keep track of the after effects or adverse reactions??? • I read all these people in pain due to star
close Any one got any results and fixed it. Any one removed it. I am
in pain and need advise what should I do to get rid of it.My angio
was done last year in Nov • I had Angio graphy done in Nov09. Since then
I have complained my Cardiologist Dr. Slayah many time that I have
femoral and Groin pain. He said he has never heard in his practice
someone to have pain due to star closer. I am so much pain that I can
not take it any more. It's affecting my relationship. What can I do?
Please advise. Dr is simply in denial that this is the cause of the
pain. • I had a heart cath performed on June 23, 2009.
The surgeon used an angioseal. I am still having pain in the groin
area, shooting into my right leg. Is this normal? I was told the seal
would be dissolved within 60-90 days. I still cannot touch the area
where is was used. • I had an angioplasty done day before yesterday
and i have very little if any bruising in my groin. They reopened a
blocked subclavian artery in my left arm last oct and closed it with
a starclose devise. This was also done the other day Aug 24th 09 so
i was under the understanding that these dissolve after a few months.
It is sounding now like they stay there. I have 2 in the right femoral
artery and I now have intense cramps on that side along with chest
pain in the center of my chest and throughout my stomach. as though
a metal clamp is compressing my internal organs. I am experiencing
headaches and pain as i walk. Should I be concerned of a blood clot
forming and moving to my heart? I have high blood pressure and I just
want to be well again. Does anyone have these symptoms and do you think
i should call my dr.? • I am a 47yo nurse.In April,2007 I had a cath/PTCA/Stent
and was closed with Angioseal. After 2hrs of bed rest I walked in the
hall and was fine. I got up the next morning to shower and experienced
a severe burning sensation and pain in my groin. I had developed a
huge bruise from lower abdomen to mid-thigh. My cardiologist was contacted
immediately and I was on 4hrs of bed rest with a sandbag.He discharged
me that afternoon. After getting home, my leg was heavy and my calf
cramped unbearably walking 100ft. My cardiologist brought me in and
ruled out blood clots. 2wks went by without further improvement so
he brought me in for arterial dopplers which also proved normal. Again,after
another 2 weeks and no improvement he performed stress dopplers which
showed very little blood flow. He immediately scheduled an angiogram
with run-off that revealed 100% blockage to anterior, posterior tibial
and peroneal arteries. All due to Angioseal shooting down my leg. This
led to an overnight in CCU with Urokinase and repeat angiogram/stent.They
were unable to open the ant. tibial and peroneal. So,I continue to
deal with pain and now the stent is closed. I'm having another angiogram
on 8/28. • I had a cardiac cath done in approx. 2005
or 2006. Have developed pain in in groin at the puncture site steadily
increasing in level over the last 2 yrs. They did use a Star closure
device without my knowledge. I am a nurse and began to search for answers
and found this site. Is it possible to electively remove the device
without major surgery? The persistent ache and heaviness of the right
leg makes working difficult. • MK -- we hate reading stories like yours...where
a vascular closure device caused a serious complication. Again these
are a small percentage, but they happen. It's one reason we have been
promoting the radial (wrist) access site on Angioplasty.Org -- which
has been shown to have fewer complications and uses no closure device.
No method is perfect, however. You might want to consult with an interventional
cardiologist or radiologist, specifically one who is experienced in
placing stents in the peripherals for a second opinion. • It has been over 2 years now & I am very concerned
about the starclose device I have post cardiac catheterization After
reviewing carefully all information regarding this device, I would
like to know why patients are not being asked if they have any metal
allergies. I have a reaction to nickel. In the last 2 years I have
gotten several rashes, chronic fatigue, and the severe pain, spasms
of my femoral artery are very intense at times. I truly do not know
where to go for advice. I noticed one person said they had an MRI.
Would that indicate if there is a problem with the starclose? Anyone
out there know if this device can be removed?? I was told I had clear
arteries at the time of my heart cath, but now with all these issues,
I wonder if plaque isn't collecting on this foreign object in my artery
causing occlusion & or spasms of the artery. • David -- while it may be the StarClose device that is causing the nerve problem, it may also be that the nerve was traumatized/injured during the needle stick and catheter procedure. A number of patients in this and our Forum Topic on "Complications from Femoral Site During Catheterization" report similar nerve problems, not limited to procedures where the StarClose is used. We at Angioplasty.Org agree that these types of problems,
and vascular complications in general, are significantly under-reported.
And prominent cardiologists agree with us. Part of the problem is that
once people leave the hospital, or the cath lab, problems they may
be having are dealt with by a general MD, or the ER, or a vascular
surgeon, and the feedback about complications often never gets back
to the interventional cardiologist, let alone the FDA. One thing patients
can do is to report
complications directly to the FDA. Another is to look to practices
where the radial
(wrist) approach is used. Complications, especially bleeding complications,
have been shown to be far lower when catheterizations and procedures
are done via the wrist -- the problem is that few U.S. cardiologists
use this approach. By the way, angioplasties done via the wrist need
no closure devices -- hemostasis (bleeding) is stopped by a simple
pressure band. As for complication rates reported by the companies,
these are based on the initial trials that were used to get FDA approval
for the device. In the case of the StarClose, that trial consisted
of a total of 208 patients. For more information, read the FDA
Approval Letter from December 2005. • Update for David Newton. Based upon the placement of the Starclose device being in close proximity to femoral nerve, there is no doubt to me that the 3 mm disc is causing intermittent impingement upon my femoral nerve. This has caused severe pain and numbness down the inside of my right leg to varying degrees. I have an appointment with a vascular surgeon next week for a consultation. I recently saw the cardiologist who placed the device who stated that it was impossible for the Starclose disc to be causing a nerve problem. I referred him to look at this Web site before he made any conclusions. Here's the problem: The main complication in the literature is vascular injury. This is frankly a obvious objective finding and can't be ignored. It must be reported. Our problem: Pain is a subjective finding and can
easily be dismissed. Therefore it can be omitted from the complication
data reported by Abbott labs.The post procedural pain IMO is being
ignored (like mine was) and as a result is not being reported. The
only other plausible theories for persistent pain are local sensitivities
to the nickel/titanium alloy causing an inflammatory response. I WILL
FIND THE CAUSE! • Had two angiograms
done, both used Star closer [StarClose] devices. Everything was great
for 2 months. Now I am having sharp pains in my artery in my groin
area. Foot goes numb, and I am having muscle spasms in my leg. • Gerri -- product and safety information for
the StarClose can be found here on
Abbott's web site. Most of the information you might want is probably
on this page. The main reason for the card is to let a possible future
cath lab doctor know that you have a StarClose clip (it's permanent).
As the web site states, "The safety of repuncture at any time
through any part of a previously deployed StarClose Clip, and the safety
of subsequent closure of this repuncture using the StarClose Vascular
Closure System, have not been fully established." If you
want a card and pamphlet, we're sure that Abbott Vascular would be
happy to supply you with them. You can call the division at (800) 227-9902. • I had a procedure 3 days ago and the doctor
used the StarClose Device. I haven't had any problems, but the nurse
did not give me the pamphlet & card that I'm suppose to have. How important
is it that I carry the card and how could I get a replacement? • well, as far as i know the clot that i had
was there before i went to hospital, that's what my hubby said, i have
very little info on all the hospital stay, as a matter of fact they
sent all my records to another facility that i had never been to even
tho i had told them where my records were twice,so not only did i have
to deal with all the extras with the pain and suffering, i had to tract
down medical records that i might need for a later date, omg what a
journey this has been, my lab result were i need to increase the med
for the clot, this i got on my own after a nurse at a clinic i use
was kind enough to read it for me this has been a roller coaster ride
for me when i had the cath done the doc, came in about 5 hrs later
and said i can go home he said that medicare didn't like patients to
stay longer than needed well were tircare and his comments were rude
and not welcome by me or hubby who served in the army for 27 years
now i will schedule a appt with the clinic that i do go to and just
go from there the closure still bothers me in the groin area. i don't
know about the metal that they used only time will tell what i need
to do good luck to us all. • I had my second heart cath done on 4/13/09.
I clip was used without my prior knowledge. Yesterday I noticed it
was tender in the area and is getting worse all the time. The doctor's
office says go to the ER, etc., if it gets worse. Sure...Let's hope
it goes away on its own. Have any of you sued or had your cardiologist
to cover the subsequent expenses from their mistakes? • Terri (et al) -- we recommend readers to also
check out the "Related Topics", especially the first one "Complications
from Femoral Site During Catheterization" -- some of the problems
described below may not in fact have anything to do with the vascular
closure device, like Angio-Seal, StarClose, etc., but may be complications
from the femoral access site or the procedure itself. Terri -- were
you informed that your blood clot problem was related to the Angio-Seal?? • hi there i had angio seal placed in my thigh
after a heart cath was done here's how it was explained to me the doc
will use this or this and if you're lucky he'll use this and you will
not be flat on your back for hrs..well how wrong were they next day
when getting ready to leave the hospital passed out and they barely
found a pulse (this was from the pain) was so severe i was in shock
was put back to bed , they found a blood clot in my right leg below
my knee they say not large but enough to put me on blood thinners and
stay another 5 days, wow so much for that procedure getting me out
the hospital fast my blood pressure was high the whole time i was there
another reason they kept me finally after my release and the doc. telling
me there will be nothing to worry about and i can resume normal duties
at work and at home..well this hasn't been the case i was admitted
on the 18 for extreme high blood pressure and they did the cath to
ensure that my heart was ok now that i am home things are terrible
i can barely walk the pain is unreal and while i was going thru my
papers that's when i found the paper with the procedure that i had
done, wow something that was suppose to get me out the hospital done
just the opposite now its the 27 july and i an taking pain med and
was advised to return to the doc to get checked out this stinks i raise
two grad kids children and don't think i will be able to return to
work soon. I have a very good boss so i don't have to worry still we
need to have more choices not the doc. • I had a uterine fibroid embolization on July
1, 2008. I had normal/tolerable pain right after procedure. This device
was also used. Had no problems until about 1-2 months ago (almost at
one-year mark). Now I have pain in my right leg/groin. At night when
trying to sleep with legs bent, I can not. This is when the pain is
worst and I have to stretch my leg out to sleep. After 2 back surgeries,
I sleep better in fetal position with my knees bent. No longer able
to sleep well. :( Seeing the Dr. again 8/4. • Update for David
Newton Please read my
July 14th post first: I had an MRI done on July 18th 2009 with
and without contrast. The results concluded that the Starclose device
was placed too far laterally in the femoral artery and was in close
proximity to the femoral nerve. There is now no doubt as to the cause
of my persistent leg pain. I can think of only one solution though
and that would be costly vascular surgery. I can't believe the cardiologist
placed this foreign object into my body without any prior verbal disclosure.
I received a pamphlet only after the procedure was done. This IMO is
clearly a violation of patient rights. • my sister also had an angioseal in her left
groin. it detached and was found down her leg after 2 weeks in the
hospital. she had a surgeon remove part of it and now 8 months later
is having the same problem. they are not sure they got the whole thing
out and it lodged in behind her knee cap. this is the third operation
and she is still having a hard time walking. nobody has any answers. • Had second angioplasty on July 16 with AngioSeal
to close...first time having a device and last night had a electric
shocking pain that it jolted me in the bed. The pea size knot is there,
but I can also feel the length of the seal...is that supposed to be?
Also, I walk with a little limp on the right leg (where the device
is located) and wonder if it slipped out of place (?) Any advice will
help, thanks. • my seal has been a year ago through various
doc's (I forgotten about the actual seal) now have narrowed it down
to the seal, the Dr.'s office won't talk to me personally?! about any
complaints. I'm at a loss. • Hello, I had
an angiogram done in October 2008 and had the Starclose device placed.
When it was time to get up in the recovery room, my whole leg was numb
and stayed that way for several hours. As the numbness went away pain
developed and was severe down the inside of my leg and thigh for several
weeks. The doctor ordered a sonogram to determine whether I had an
aneurysm of the femoral artery. I was upset in the first place because
I have an autoimmune disease and would not have consented to a foreign
body implant. I thought the problem would go away as I thought they
had probably stuck my femoral nerve with the local anesthesia and when
it persisted I then thought perhaps they nicked the nerve with a scalpel.
But now I'm absolutely convinced that the Starclose disc is chronically
and intermittently impinging upon my femoral nerve. Many times foreign
objects will develop scar tissue and enlarge over time. That 3mm disc
could now be a 5-6mm scar tissue ball. The only option I know of is
to consult a vascular surgeon. It may be remotely possible that ultrasound
could help with pain but not entirely likely. Even a lidocaine patch
may work as well. I might try that....It has been 9 months now and
today I can't walk because of an acute "attack". This is the worst
in a long time. So it is evident that this complication is not going
to go away. As a result I called the surgeon's office and I'm going
to ask for a CT scan to see what's going on. Good luck to all of us!
We will need it. • I need help. My wife had an arteriogram done
last year (June 2008) related to an AVM in her brain. The last few
months however she has been in searing pain which has kept her up or
affected hr in other ways. She has had ultrasounds done by her general
doctor but those have shown nothing. The surgeon who did the procedure
has not returned any calls yet and we are worried. After reading some
of these posts I wish the doctors would have been more forthright about
this. If I knew the type of complications my poor wife would be having
I would have forgone this procedure. Any advice is helpful. Thanks. • I just had my catheterization done yesterday.
The StarClose was used to seal my artery and today I went fishing,
played a little badminton with the kids and took a short hike. All
of this was done carefully, slowly, and with the doc's permission.
There was no pain associated with any activity and I anticipate a full
return to work with no restrictions after my follow-up appointment
on Monday. As far as I'm concerned, the StarClose device worked perfectly. • Mike -- Good questions. The StarClose device
is a small nitinol (nickel-titanium) clip which grasps the outside
of artery slightly to achieve hemostasis (stopping of bleeding). Nitinol
is a metal which does not degrade so it is there permanently. It's
on the artery itself, so it is under the skin. You can read more and
see a photo here. • I had angioplasty 2 weeks ago today and the
artery was closed with a StarClose. Everything went extremely well
and I'm having no problems at all. I'm merely curious as to what happens
to the Starclose device? Does it get enclosed by scar tissue? Does
it deteriorate or stay intact? Can it come loose? I can't find this
info anywhere. • Anyone who has
had a vascular closure device placed should bypass his/her family doctor,
bypass his/her cardiologist and seek a vascular surgeon for evaluation.
The statistical likelihood that there will be a complication is likely
to be greater than 10% and this contradicts what doctors and websites
will tell you. If you are feeling poorly in a matter of days to weeks
after angioplasty should go to an emergency room. Anyone contemplating
angioplasty should tell the doctor they do not want a vascular closure
device and ask the doc to chart that in the medical record. For decades
a nurse holding pressure with sandbags and bed rest have been safe & effective
when the nurse is diligent. A vascular closure device is just another
way to tag $500-$600 onto your hospital bill.In theory, the vascular
closure device should make it possible to leave the hospital or outpatient
clinic earlier safely without risk of bleeding, infection or other.
It is not worth the risk, and I would not advise my family to have
one used. Go to the FDA MAUDE database to read more about complications
(adverse events) with vascular closure devices.How do I know all this?
I'm a nurse who was fired for truthfully reporting too many adverse
events that occurred after vascular closure device use. • I had a diagnostic angiogram in April. At
my appointment prior to procedure, I specifically asked exactly how
it was done, how they closed artery and even how the 2% complication,
bleeding, was addressed. My dr. said that, other than the sandbagging,
complications would be surgically sewing the artery to stop loss of
blood and that since I'm thin wouldn't be an issue. I was specific
about having nerve issues from previous inguinal hernia repair and
having to have those staples surgically removed to release the nerves
that were pinched. During the angiogram, I was not sedated, there was
NEVER mention of anything until the stapler popped the Starclose into
my groin. The pain was bad enough to make me scream and I've always
been tough. The pain since has been bad enough to interfere with my
daily life. I'm worried that I'll need to have it removed to save the
nerve that was apparently pinched. But, if I have that done, am I taking
even bigger risks with my life than dealing with the pain? My dr. is
saying that the closer was a favor so that patients can go home quickly.
I'm very sure that it was a time saver for him and his staff and that
he didn't disclose it so that I wouldn't refuse it, which he would
be right in assuming. I hate that I'm living my life differently now
because of my doctor doesn't think it's a problem and won't take responsibility.
I'm also worried about what they WON'T tell me. What is the truth?
I'm 54, raising my grandchildren and can no longer just do what I want
because I'm in pain. I really don't know where to go from here. • I have the Angio Seal and unable to peel
the dressing off. Sounds stupid I Know but how do you get the clear
adhesive started and then peel off? I can't get it started. • I had an angio-seal inserted about two weeks
ago. I have progressively had more and more pain in my right calf and
thigh. I am not able to do any kind of exercise. Is this normal or
a problem? • I had a heart cath done on 05/28/09 and the
angio-seal was placed in my femoral artery and I have been in pain
every since. The day of the procedure I was in so much pain as they
tried to get me to walk just 2 hours after the procedure. It's going
on 4 weeks now and I still can't get back to my normal active self.
I have electrical shooting pains in my thigh and groin area, and at
time a stinging pain at the groin site. I can't stand or walk as usual,
It hurts daily. I'm going to the doctor in the morning. Will post what
they tell me. • I had a thrombosis of the subclavian artery
on my left side affecting my left arm. On March of 09 they went in
and put three stents in, going through my right groin and left radial
in my arm. Arm seems to be doing fine as far as where they went in,
arm still isn't any better though since they cleared blood clot. Where
they went in through right groin I had a huge hematoma, almost immediately
coming out of procedure, went across stomach and down right leg, had
to be sand bagged for hours and hours, then they made me stay overnight.
Have had nothing but problems with site, didn't even know until two
weeks later when they did another cath through this time right arm
radial, that they had used star close and at that time gave me a brochure
on it. Its now June, it stings and burns and is very painful and for
no rhyme or reason bleeds, forcing me to keep a bandage on it most
of the time. I've told my cardiologist almost from day one of the procedure
of all my problems, but he just seems to say oh it will be okay in
time. I don't believe them, and now am scared to death and don't know
what to do. Please, Please if anyone can help me, let me know. jirwin59@peoplepc.com
Thank You for this site, I'm in disbelief and horror of all the things
I'm reading. • I am 42 years old had a catheterization 2
days ago with angio-seal was used doctor never gave me options and
just handed pamphlet to my husband after procedure i have many allergies
and autoimmune disease doctor did not read my chart in pamphlet it
states if you have this disorders that doctor should be aware before
using angio-seal i now have severe pain in groin area going down the
front of my leg along with numbness and can't walk and i am on pain
killers ultrasound was normal and er doctor had no clue what this device
was all about is this device used to save time and money? i will pursue
to get more info from doctor who did procedure 5-29-09 has anyone have
a specific answer or gone through same experience? • I had two Angio seals installed in right groin
3-11-08 and 4-24-08. Last five months my right leg is hurting and loosing
range of motion, can't cross the leg or put on my socks. I need information.
I mentioned to my primary care physician and he gave me anti-inflammatory.
Anyone else have same problems. • WHAT IS THE TIME LIMIT (SAFE) AFTER HAVING
AN ANGIO-SEAL IMPLANTED FOR A PERSON TO HAVE SEX? • i am a 44 year old man that had an arteriogram
a week ago. A starclose device was used. I have had severe pain at
the site and i can feel the device right under the skin. Does this
pain go away with time or should I be concerned? Has anyone else had
this problem? • I am two days post op from cardiac catheterization
with a Mynx closure device. Doing great, only minimal pain yesterday,
no bleeding or oozing. • I underwent angioplasty on 4/30/09 and am
thrilled with the results. However, I am not thrilled with the Angio-Seal.
Here it is 6 days post-surgery and the pain, while not severe, is uncomfortable
at the seal site. I can't even walk around the block without discomfort
in my right groin area. If I put pressure on the site, the pain is
reduced, much like the relief one experiences when using underwear
that put pressure on a herniated area. • I'm 21yrs old and I had a starclose put in
a year ago and I'm still getting a lot of pain in the area of my starclose.
My leg will randomly swell up, get red, and feel hot to touch. Every
time I go to the ER they do an ultrasound but they can never find anything
wrong. I'm just wondering if anyone else out there is experiencing
the same problems. I also have problems with it hurting when it gets
really cold too. • I just had a diagnostic heart cath done on
Monday 4/27/09. I have not had a negative effect as yet to the Angio-Seal,
other than raised blood pressure, but it seems to have leveled off
to an acceptable level. I am concerned however that I am required to
carry a card stating that I had this procedure done. That concerns
me. 90 days is a long time. What can I or can't I do after this procedure
that I've not been told about? I refrained from driving the two days
they say. NO baths for 5. No lifting 10 lbs or more for 2 weeks. That
pretty much sums it up. I was given Versed before the procedure, so
if anyone discussed anything else with me, I sure don't recall it. • I am having severe pain in my thigh and groin
after an angioplasty two weeks ago. A venous doppler scan ruled out
blood clots. Pain medication just makes me sleep and I am still in
pain. I see that several people have written to your forum about similar
problems. Has anyone found and answer to the problem? • Phillip -- a very small percentage of people
are hypersensitive to bovine collagen, which is the active sealant
in Angioseal. You might want to check with an allergy specialist if
this might be the case. • I had the angio seal device put in after an
arteriogram on March 5, 2009. ever since then i have had hot flashes
and body sweats. i do not run a fever but i feel hot inside everywhere.
can this be a side effect from the angio seal? • This is an update
to my post on March 12 regarding the starclose apparatus sticking
out of my skin. I went to the surgeon and the explanation was that
the skin is supposed to grow over it; it then disintegrates over
time. The surgeon believes that since I am thin and don't have a
lot of excess skin in the area, it didn't heal over it as it was
supposed to. The surgeon ended up yanking it out of my skin - ouch
- and the area has now fully healed.Also, the lumps in the groin
area have gone away. I was told they were lymph nodes that may have
been enlarged and part of the healing process. Yesterday I had another
pulse volume recording test, and my right leg did not do very well.
Back for angioplasty I go at some point in the future. • I had an Angio-Seal inserted on January 14,
09. I had significant bruising and indications that blood was trapped
in the tissue, It was sore and had the knots that protruded. I had
pain in my right leg where the device had been installed. I am experiencing
significant blood flow loss to my right leg. The pain is from inadequate
blood flow to support walking any distance. A second angiogram performed
and appears as though a string has reduced the maximum size of the
artery to about 1/2. The blood flow reduction has been confirmed with
doppler flow and I am scheduled for surgery to go in and see what is
or has happened and return normal blood flow to the right leg. Walking
with reduced blood flow to the entire leg ia painful as ling as you
are walking, but ease soon after sitting. • I am an Insurance Administrator-my client
submitted a claim with a Discharge DX as "Post catheterization complication
occlusion of right femoral artery, status post surgical removal of
foreign body - Angio Seal - Should the Insurance be held responsible
for payment of this expense? • i been home 3 days from angio seal I am in
sooooooo much pain, I look like I am 10 months pregnant I ache all
over and hard to walk and I feel so full I never ever hope ANY One
gets this done! This is the WORST Thing I ever did in my life! Headed
to the ER. • Having not been advised of Starclose before
cath other than a pamphlet -- would have never agreed to it. Informed
consent is a part of patient's bill of rights. Any lawsuits because
of physical harm? • I am a 30 year old extremely fit male whom
has a venous malformation on my right foot. In order to find the extent
of the malformation I underwent a arteriogram on 3/9/09 in which Dr.
went into left side of groin into right femoral artery. I was closed
with the Angio Seal device. I was in extreme pain two days following
the procedure. It has been a week and I can't stand up straight as
I have a very uncomfortable feeling near where the insertion was made.
It feels like a lot of bloating or the pain you feel when one holds
there urine for long periods of time. Is this normal as it has been
only a week, or is recovery time normally faster. I can't return to
work, I work in Law Enforcement and it hurts to walk not to mention
run or move to quickly. I can't stand up straight due to the pain in
the lower abdomen and top of groin. There is no visible bruising just
uncomfortableness. Someone please help. I want to get back to work.
The Dr. never told me about a Angio Seal and I think it was done to
expedite time seeing as though the Dr. was hours late; and I was originally
told that I would have to lie still in bed for several hours. • JL -- that's something we've haven't seen
reported on this Forum before. Please update us when you find out more
from the surgeon. • I am a healthy 45
year old woman who had vascular angioplasty in both legs along with
a stent. It has been 3 weeks since surgery, and today I noticed what
I thought was a scab at one of the incisions, is apparently the StarClose
sticking right out of my skin. On top of that, on both sides of my
groin where the incisions were, I have almond sized lumps in the area.
I'm wondering if exercising had something to do with all of this? I
am going to the Surgeon tomorrow, but can not believe I was told nothing
about this "StarClose" other than the yellow-type-sticky that was placed
on the incision after surgery. What are they going to do, have to remove
it since my skin didn't heal over it? The thought is making me sick. • I am a 52 year old female. I had a catheterization
done three days ago, which was clear, this was closed with an angio-seal.
I was not told before hand this thing would be in me for 90 days. I
have has some discomfort and pain on walking and the first night a
bit of a fever. The discomfort is not so bad now but I am still concerned
about this thing in me for 90 days. Should I still be careful with
what I do,can I go back to work my job entails me standing for most
of the day.Can it dislodged during this 90 days? I really think you
should be told more about the after effects and after care and yes
I did ask and was given a piece of paper with a few guide lines on
it. Nothing said about the pain when first walking!!! • My Dad had the angio seal placed on Feb.12,
09. He was not told about it or given a choice. I thought it was a
good replacement for the manual pressure. However after reading all
the comments, when he goes in for his ablation, I will be sure to ask
what the other options are. • In response to Maureen
T. I hope your numbers regarding your friends hypertension is
a type -o, 210 over 200?? As for why hypertension is a contraindication,
any patients b/p must be under control,(most hospitals have there
own guidelines) prior to pulling the sheath from the artery. The
higher a patient's blood pressure is exacting force on the puncture
site, the harder the bleeding would be to stop, or control. Usually
on call meds are available for someone with hypertension to reduce
the force on the arterial wall prior to pulling the sheath.If a patients
blood pressure remains uncontrolled, better control of the artery
and reducing bleeding is usually best obtained by direct manual pressure
or by another device called the fem-o stop. In the opposite circumstance,
medications are available if the patients blood pressure should be
too low as well. Fluids and or meds could be given to help obtain
a more stable pressure prior to sheath pull if the pressure is too
low. I hope that helps. • Just a reminder to readers -- if you look through this topic and the related topic on "Femoral Complications", you'll read a number of stories that might make you too afraid of a very widely-used procedure. Just remember that this Forum is, by its nature, the "Complaint Department". People seldom write in to say, "I just had a cardiac catheterization and it was wonderful!" But if they have a problem, they go to Google and wind up here! Yes, there are complications with any medical procedure.
In this case serious complications are in the very low single digits.
However, less serious complications or discomforts that are important
to the patient also exist, as evidenced by this Forum. If you are having
a problem, getting an answer from the doctor that there is nothing
wrong might make you think you're imagining things (it's in your head,
not your leg!). The reason for this Forum is to support your self-knowledge,
but hopefully not to scare you. For some perspective, read this
excellent post from M.G. in West Virginia from someone who has
had a problem, and has good advice. • Hello my name is Misty and my mother in law
has had an Angio-Seal done back in August 2008. I am now concerned
for her well being. I have read about these complications which are
similar to hers. I am wondering if someone out there can give me a
update on the current symptoms , if they worsen or are new ones. Possibly
found relief??????? Please send feedback. Thank you. • I had an angiogram about 3 weeks ago and also
had an Angio-Seal closure. I have had no difficulty with it until the
last few days. It is not painful but there is a little "picky" feeling
at the site. No bruising. Just this sharp on and off impulse at the
site. Cause for concern? • I had an angiogram in October 2008, I was
in so much pain for 2 months and complained to my doctor about this.
Finally, he sent me to have a ultrasound and was told that there was
nothing wrong just my lymph nodes around the sight were swollen because
of the poking around. I also had a low grade temperature for about
a week. Well, its now February 3, 2009 I'm writing this still having
pain not as severe, but it interferes with relations, walking or crossing
my legs. I worry that the thing may cause more harm than my TIA did. • I had my tenth angioplasty 1/2/09 during which
an angioseal was inserted. Because my angina did not resolve I was
kept in the hospital and on 1/5/09 I felt a small "pop" in my groin,
then a big "pop", called the nurse who called a "code". The next I
knew one of the cardiologists (fortunately this was during"rounds")
was applying pressure to my groin, I was introduced to the vascular
surgeon who would repair the artery and we were speeding to the O.R.
Two more weeks in the hospital and several transfusions later I came
home but still need nursing care, I was able to live independently
before this incident. I hope I can once again. It is now 2/2/09. • This is my second
post regarding the Starclose closure device. I have read several if
not all of the posts and posters need to know that there are several
ways of securing the arterial site post cardiac catheterization or
angiography/arteriogram. Starclose is the type of device used after
my negative cath in 2007 and in which I posted in May, 2008. After
my deployment of Starclose device I had excruciating pain for a year.
My right groin site is now tender but tolerable. Most days i don't
even notice it as still being tender but it is still noticeable on
other days. Having said that, I must tell you that no procedure is
without risk. I have every confidence in the cardiology group that
did my procedure. I was just a little dismayed at first when I found
out that the starclose, unlike angio-seal or boomerang procedure, or
the Syvek, chitaseal patch that are only temporary: the starclose remains
permanently in the artery and it only makes sense to me that it could
potentially create an area of occlusion in an otherwise normal artery.
Having said this, as I read others posts who say they are afraid to
continue with angioplasty even though they have 100% blocked arteries,
I have concerns that people are not going to receive appropriate interventions
due to fear. I would just like to say, communication is the key and
no matter how hurried you are to get the procedure over with or how
busy the Dr. is, make certain all of your questions have been thoroughly
answered prior to consenting. I do not regret having had my heart catheterization
and I must accept my responsibility in the process of patient care.
I should have asked for a time out to think about this new procedure
(starclose) before I consented to it. I hope no one reading this will
delay important treatment due to fear. Ask questions and DEMAND your
answers before you sign. Thank You. • Debra -- the bruising is a hematoma -- bleeding
under the skin. It's usually a small amount which is not uncommon,
but if it gets larger in size, call your cardiologist. • i just had a cardiac cath. done on jan. 06/09
and i have a hard lump below the site and my leg is turning black and
blue, it this normal? • Hello. Has anyone had a successful lawsuit against St. Jude's for an AngioSeal STS used in 2005-2006 for migration down the leg? Or any other problem with it moving? If anyone has the instructions for the product from October 2006, I'd appreciate receiving a copy. This is a wonderful page and the editors are to be congratulated. A friend had complications with an AngioSeal STS
being used in October 2006. She was very obese and it is likely that
it didn't actual get installed properly. It went down to the calf of
her leg and had to be removed surgically. I saw the pathology report
and it said that the suture was attached to one piece and a piece of
bone to the other. All of this and no coronary artery disease. Anyway,
I was looking to find the instruction book for 2006 because the one
now on St. Jude's web site is from 2007. I would like to look and see
what was contraindicated at that time, such as obesity and if it was
of concern that she had blood pressures of 250 over 200. If anyone
has one please let me know by emailing me at mat296Q@gmail.com.
Also I don't understand why they indicate hypertension could be a problem
using an AngioSeal STS Anyone understand why? |
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