BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH AAA LEG EXTENSION DELIVERY SYSTEM

    MDR report key: 1070931 · Received July 3, 2008

    Report

    Report Number
    1820334-2008-00382
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IN 2008, A MALE UNDERWENT INITIAL AAA REPAIR AS LABELED, (PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR). BLOOD LEAKAGE OCCURRED FROM THE HEMOSTATIC VALVE OF THE MAIN BODY DELIVERY SYSTEM AFTER GREY POSITIONER WAS WITHDRAWN FROM MAIN BODY. THE AMOUNT OF BLOOD LEAKAGE WAS 140CC. THE WIRE GUIDE WAS MOVED TO THE CENTER OF THE VALVE, YET THE BLOOD LEAKAGE STILL OCCURRED. TO STOP BLOOD LEAKAGE, THE MAIN BODY SHEATH WAS PINCHED BY FORCEPS. (REFER TO 1820334-2008-00381). ALSO, INCOMPLETE EXPANSION OF THE CONTRALATERAL ILIAC LEG GRAFT WAS OBSERVED BY AN ANGIOGRAPHY FROM THE CONTRALATERAL SHEATH AFTER THE GRAFT WAS PLACED. AFTER FINAL ANGIOGRAPHY, IT WAS CONFIRMED THAT THE CONTRALATERAL ILIAC LEG GRAFT WAS NOT EXPANDED APPROPRIATELY. THE PHYSICIAN BELIEVES IT IS POSSIBLE THE LOCATION OF THE GRAFT ON THE CONTRALATERAL ILIAC LEG MAY HAVE HAD CALCIFICATION. PATIENT OUTCOME UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA LEG EXTENSION DELIVERY SYSTEM MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2155866

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR