BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCLOSE VASCULAR SUTURE DELIVERY DEVICE

    MDR report key: 19860171 · Received July 26, 2024

    Report

    Report Number
    MW5157770
    Event Type
    Other
    Date Received
    July 26, 2024
    Date of Event
    July 24, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, AFTER SUCCESSFUL IMPLANT OF A SAPIEN 3 ULTRA RESILIA VALVE IN THE AORTIC POSITION, A PERCLOSE FAILURE OCCURRED RESULTING IN A MAJOR VASCULAR COMPLICATION. A UNPLANNED VASCULAR SURGERY WAS PERFORMED. THERE WAS NO ALLEGATION OF ANY EDWARDS DEVICE THAT CAUSED THE EVENT. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280917 PERCLOSE VASCULAR SUTURE DELIVERY DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown