BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 23554237 · Received November 14, 2025

    Report

    Report Number
    23554237
    Event Type
    Malfunction
    Date Received
    November 14, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 27, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT CAME TO OPERATING ROOM FOR PROCEDURE OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR). DURING PROCEDURE, ATTENDING SURGEON ATTEMPTED TO USE ENDOVASCULAR CLOSURE DEVICES, PERCLOSES. SURGEON NEEDS X4 PERCLOSE TO COMPLETE CASE. X7 PERCLOSES WERE OPENED FOR CASE, 3 WASTED AS THEY DID NOT DEPLOY PROPERLY. PERCLOSE IS MADE BY ABBOTT MEDICAL, REFERENCE NUMBER (B)(6). THE LOT NUMBERS FOR THE MALFUNCTIONING DEVICES ARE 5080841, LOT NUMBER 5072641 EXPIRES 06/30/2027 X1, AND LOT #5081442 EXPIRES 07/31/2027 X 2. SURGEON WAS ABLE TO RECEIVE ADEQUATE RESULTS WITH PERCLOSE CLOSURE DEVICES X4 AFTER DISCARDING FAILED PERCLOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832922 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 5080841

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female