BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG DELIVERY SYSTEM

    MDR report key: 1062599 · Received June 18, 2008

    Report

    Report Number
    1820334-2008-00326
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA REPAIR IN 2005. ONE MAIN BODY GRAFT AND TWO ILIAC LEG GRAFTS WERE PLACED WITH THE LEFT LIMB HAVING ONLY 1 CM OF PURCHASE INTO THE LEFT COMMON ILIAC. OVER TIME, THIS LIMB POPPED INTO THE ANEURYSM SAC CAUSING AN ENDOLEAK. IN 2008, THE PHYSICIAN PLACED A WIRE UP THE LEFT SIDE AND USED ANOTHER ILIAC LEG GRAFT TO EXTEND THE LIMB DOWN TO RIGHT ABOVE THE LEFT INTERNAL ILIAC AND OBTAINED A GOOD SEAL. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG DELIVERY SYSTEM MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC. NA 1492727

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention