All concepts, explanations, trials, and studies have been
re-written in plain English and may contain errors. I am
not a doctor
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Complications Related to the Use of Vascular Hemostasis Devices
October 8, 1999

I am writing to inform you of adverse events related to the use
of vascular hemostasis devices. These devices are an alternative
to manual compression in achieving incision closure in femoral
artery puncture in patients having a cath. Reported
complications related to these devices include bruising,
retroperitoneal bleed, pseudoaneurysm, late bleeding, and
infrequently, death.

Since 1996, the FDA has received reports of adverse events,
including deaths, concerning closure devices. In one case,
a patient, who had previously been treated with such a device,
had a heart attack. During the ensuing catheterization, the
closure device was dislodged, requiring surgery to correct.
In another case, following closure with such a device, the
patient was discharged but had to return days later with
bleeding from the groin. This patient then required surgery
to repair a ruptured pseudoaneurysm.

Complications can also occur when manual compression is used
after a cath. Review of the literature shows that complications
with manual compression are similar to those with closure
devices. After analyzing the specific circumstances in these
cases, we believe the following guidelines will help minimize
adverse events related to the use of these devices.

Recommendations

Manufacturers’ instructions and recommendations vary for
individual vascular hemostasis devices. To avoid complications
when using them, carefully follow the device manufacturer’s
warnings, precautions, and instructions regarding patient
selection and device use.

In addition, we offer the following specific recommendations:

1) Do not use vascular hemostasis devices to treat patients
with suspected double wall punctures, since punctures of the
posterior wall are not closed with these devices.
2) Carefully weigh the risk of bleeding at the puncture site
against the benefits of using a closure device when treating
patients with bleeding disorders or patients taking platelet
glycoprotein IIb/IIIa receptor inhibitors. (blood thinmners)
3) Carefully monitor the groin puncture site to minimize the
occurrence of complications with these devices.
4) Special attention should be paid to any post-procedure
patient-management instructions for the specific device used.

If you have questions regarding this letter, please contact
Paula Simenauer
Office of Surveillance and Biometrics (HFZ-510)
1350 Piccard Drive
Rockville, Maryland, 20850

By fax at 301-594-2968 or by e-mail at phann@cdrh.fda.gov