BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1194572 · Received September 9, 2008

    Report

    Report Number
    1820334-2008-00581
    Event Type
    Injury
    Date Received
    September 9, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 10, 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 EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING AAA REPAIR IN 2008, IT WAS DETERMINED THAT THE MALE'S ANATOMY WAS SUITABLE FOR ENDOVASCULAR THERAPY. THE PROCEDURE WENT AS LABELED, BUT AFTER THE DEPLOYMENT OF THE IPSILATERAL ILIAC STENT, BLOOD LEAKAGE OCCURRED FROM THE HEMOSTATIC VALVE WHEN THE PHYSICIAN WITHDREW THE GREY POSITIONER. AFTER WITHDRAWING THE GREY POSITIONER, THE PHYSICIAN INSERTED THE DILATOR OF CONTRALATERAL ILIAC LEG DELIVERY SYSTEM INTO THE HEMOSTATIC VALVE TO RESTRAIN THE HEMORRHAGE. THEN, A BALLOON CATHETER WAS INSERTED INTO THE IPSILATERAL LEG. TOTAL HEMORRHAGE VOLUME WAS 620CC. SO, 400CC OF BLOOD WAS TRANSFUSED TO THE PT. THE PT HAS RECOVERED.

    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. NA F2205558

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention