BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA MAIN BODY GRAFT

    MDR report key: 1000466 · Received February 21, 2008

    Report

    Report Number
    1820334-2008-00087
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 25, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING AAA REPAIR IN 2008, THE MAIN BODY GRAFT WAS DELIVERED NORMALLY AND DEPLOYMENT WAS ACCORDING TO COOK'S INSTRUCTIONS FOR USE. ONCE THE TOP CAP WAS CAPTURED, THE GREY POSITIONER WAS WITHDRAWN THROUGH THE VALVE WITH NO RESISTANCE. WHEN THE GREY POSITIONER EXITED THE VALVE, LARGE AMOUNTS OF BLOOD FLOWED OUT OF THE VALVE, ALMOST LIKE THERE WAS NO VALVE PRESENT. THE DILATOR TIP OF THE GREY POSITIONER WAS ADVANCED BACK INTO THE VALVE TO STOP BLEEDING. AFTER THE CASE, THE SHEATH WAS CLEANED AND GIVEN TO US TO RETURN TO COOK FOR EVALUATION. WHEN LOOKING AT THE VALVE, IT WAS NOTED THAT IT LOOKS LIKE THE LEAFLETS OF THE VALVE NEVER CLOSED AROUND THE WIRE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA MAIN BODY GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other