BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1211628 · Received October 24, 2008

    Report

    Report Number
    1820334-2008-00586
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE WITH A PREVIOUS HISTORY OF HYPERTENSION AND DIABETES UNDERWENT AAA REPAIR IN 2008. THE PATIENT'S ANATOMICAL FORM WAS CONSIDERED SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WENT AS LABELED. WHEN FLUSHING THE MAIN BODY DELIVERY SYSTEM BEFORE THE PROCEDURE, LEAKAGE WAS ALREADY NOTED AT THE HEMOSTATIC VALVE. THE PROCEDURE CONTINUED BUT THE BLOOD LEAKAGE STARTED WHEN THE CONTRALATERAL LIMB OF THE MAIN BODY WAS DEPLOYED. THE PHYSICIAN REMOVED THE INNER CANNULA AND INSERTED A COOK INTRODUCER INTO THE VALVE BUT THE LEAK DID NOT STOP. LEAKAGE FROM THE HEMOSTATIC VALVE OF THE ILIAC LEG GRAFT ALSO HAPPENED (1820334-2008-00587) ALTHOUGH NOT AS BAD AS THE MAIN BODY. THERE WAS HEAVY LEAKAGE WHEN ONLY THE WIRE GUIDE WAS PLACED. TOTAL HEMORRHAGE VOLUME WAS 2000CC. THE PATIENT WAS TRANSFUSED WITH 1000CC. NO NOTABLE CHANGES WERE FOUND IN THE PATIENT'S CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. N/A F2205495

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention