BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1031194 · Received April 16, 2008

    Report

    Report Number
    1820334-2008-00248
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 12, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE WITH A LOT OF CALCIFICATION UNDERWENT INITIAL AAA REPAIR IN 2008. ONE FLEX MAIN BODY GRAFT AND TWO ILIAC LEG GRAFTS WERE PLACED. THEN THE FOLLOWING MONTH, THE PT UNDERWENT AN ADDITIONAL PROCEDURE DUE TO ONE ILIAC BECOMING OCCLUDED BUT NOT FROM A GRAFT KINK. UPON GAINING ACCESS, IT WAS NOTED THAT THERE MIGHT BE A SLIGHT DISSECTION FROM THE INITIAL PROCEDURE. THIS WAS NOT CONFIRMED, AS THE PHYSICIAN COULD NOT DETERMINE WITH CERTAINTY. THERE WAS A LOT OF CALCIFICATION BELOW THE GRAFT IN THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN SAW THAT THE OCCLUSION WAS FROM THROMBUS AND CLEANED OUT AS MUCH AS HE COULD. HE THEN PLACED ANOTHER ILIAC LEG GRAFT INSIDE THE LEFT ILIAC LEG GRAFT AND THEN PLACED TWO SELF-EXPANDING STENTS OF ANOTHER MANUFACTURER ABOVE THAT AND ONE STENT BELOW THE ILIAC LEG GRAFT. THIS COVERED THE AREA OF POSSIBLE DISSECTION. THE NEXT AFTERNOON, THE NEXT DAY, THE LIMB OCCLUDED AGAIN SO THE PHYSICIAN PROCEEDED WITH A FEM-FEM BYPASS. THE PT IS NOW SAID TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1973524

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention