BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH AAA MAIN BODY GRAFT

    MDR report key: 501195 · Received December 3, 2003

    Report

    Report Number
    1820334-2003-00244
    Event Type
    Other
    Date Received
    December 3, 2003
    Date of Event
    November 6, 2003
    Report Date
    November 6, 2003
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ORIGINALLY THE PHYSICIAN HAD PLANNED ON IMPLANTING THE THREE-PIECE BIFURCATED ENDOVASCULAR GRAFT. DIFFICULTY WAS ENCOUNTERED DURING THE ATTEMPT TO CANULATE THE CONTRALATERAL ILIAC ARTERY. THE PHYSICIAN WAS UNABLE TO INTRODUCE THE WIRE GUIDE THROUGH THE LEFT ILIAC ARTERY AFTER MULTIPLE ATTEMPTS. THE LEFT COMMON ILIAC ARTERY WAS CHARACTERIZED BY THE PRESENCE OF THROMBOSIS AND APPEARED TO BE OCCLUDED. THE PROCEDURE WAS CONVERTED TO AN "AORTOUNI-ILIAC" CONFIGURATION DUE TO THE ANATOMICAL COMPLICATIONS. PROCEDURE WAS DEEMED A SUCCESSFUL CONVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA MAIN BODY GRAFT ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1285335

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other