Complications and Failure Modes of the Perclose Vascular Closure Device: Insights From MAUDE Database

Document Type

Conference Proceeding

Publication Date

5-2022

Publication Title

Journal of the Society for Cardiovascular Angiography & Interventions

Abstract

Background

The Perclose vascular closure device (VCD) (Abbott Vascular, Redwood City CA) was the first suture mediated closure system approved by the FDA in 1997. Real-world data on the most common mode of failures and complications associated with the use of Perclose

Methods

The MAUDE “Manufacturer and User Facility Device Experience” database was quired for reports of Perclose VCD from July 2015 through June 2021.

Results

Of the 108 reports of major complications, 97 reports involved the malfunctioning of the device. The most common modes of failure were detachment or break of the device (36%; n=39), failed deployment (35%; n-38) and Entrapment (19%; n=20). The most common adverse outcome was device embedment within the tissues (30%; n=32). Other less frequent clinical consequence were vessel occlusion, vessel dissection, and bleeding. No deaths were reported.

Conclusions

Despite a high success rate, the Perclose VCD was shown to be associated with complications including device embedment, vascular injury, and bleeding which thought to be likely driven by patient vascular disease severity.

Volume

1

Issue

Suppl 3

First Page

100255

Comments

SCAI 2022 Scientific Sessions, May 19-22, 2022, Atlanta, GA.

DOI

10.1016/j.jscai.2022.100255

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