BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 23656834 · Received November 26, 2025

    Report

    Report Number
    23656834
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    September 26, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    MULTIPLE DEVICE DEPLOYMENT FAILURES OF PERCLOSE PROSTYLE CLOSURE SYSTEM (MINIMAL FOUR) DURING TAVR [TRANSCATHETER AORTIC VALVE REPLACEMENT] PROCEDURE. LOT # 5081641.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569740 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-03 5081641

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown