BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 497517 · Received November 24, 2003

    Report

    Report Number
    1820334-2003-00267
    Event Type
    Other
    Date Received
    November 24, 2003
    Date of Event
    July 24, 2003
    Report Date
    November 18, 2003
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    UPON COMPLETION OF THE STANDARD THREE-PIECE DEPLOYMENT, AN ANGIOGRAM WAS PERFORMED THAT DOCUMENTED A DISTAL TYPE I ENDOLEAK AROUND THE DISTAL END OF THE LEFT ILIAC LEG GRAFT. A REPEAT INFLATION OF THE MOLDING BALLOON WAS UTILIZED TO ATTEMPT TO SEAL THE ENDOLEAK, BUT WAS UNSUCCESSFUL. DUE TO THE LIMITED AMOUNT OF DISTANCE FROM THE DISTAL END OF THE ILIAC LEG GRAFT TO THE LEFT HYPOGASTRIC ARTERY, A MAIN BODY EXTENSION WAS UTILIZIED TO EXTEND THE GRAFT FURTHER INTO THE LEFT COMMON ILIAC ARTERY. THE DEVICE WAS IMPLANTED, LANDING JUST ABOVE THE LEFT HYPOGASTRIC ARTERY. A REPEAT ANGIOGRAM WAS PERFORMED WITH NO EVIDENCE OF ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT ENDOVASCULAR GRAFT MIH COOK, INC. NA 1210335

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other