BEUDAMED
    FDA Adverse Event Other Summary report: N

    W L GORE

    MDR report key: 1842645 · Received September 20, 2010

    Report

    Report Number
    MW5017503
    Event Type
    Other
    Date Received
    September 20, 2010
    Date of Event
    August 18, 2010
    Report Date
    September 3, 2010
    Manufacturer
    W L GORE
    Product Code
    DYB
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF SHEATH. DURING ENDOVASCULAR TRIPLE A REPAIR, THE SITUATION WAS CORRECTED. PT HAD SOME BLOOD LOSS. NO SIGNIFICANT POST COMPLICATION. POST ANGIOGRAM CONFIRMED GOOD POSITIONING OF ENDOGRAFT WITH NO LEAK. SHEATH WAS BROUGHT IN BY SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 W L GORE SHEATH DYB W L GORE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR