BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG DELIVERY SYSTEM

    MDR report key: 1073672 · Received July 9, 2008

    Report

    Report Number
    1820334-2008-00360
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 13, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE ( IFU) LISTING THE ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU ALSO ADVISES ON APPROPRIATE FOLLOW-UP SO THAT CHANGES IN THE STRUCTURE, SHOULD THEY OCCUR, BE IDENTIFIED AND ADDRESSED BEFORE CAUSING CLINICAL PROBLEMS. THE DEVICE REMAINS IMPLANTED AND NO FIRMS WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THE EVENT WAS CAUSED BY PT ANATOMY.

    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. THEN IN 2008, THE PT UNDERWENT AN ADDITIONAL PROCEDURE, DUE TO THE RIGHT ILIAC LEG GRAFT THAT THROMBOSED. THE PHYSICIAN CLEARED THE CLOT FROM THE LIMB AND PLACED ANOTHER ILIAC LEG GRAFT INSIDE THE ORIGINAL GRAFT TO RELINE IT. THERE WERE NO KINKS IN THE GRAFT OR EVIDENCE TO SHOW WHY THIS OCCURRED. THE PT WAS PUT ON COUMADIN TO FURTHER TRY TO PREVENT THE CLOTTING OF THIS LIMB.

    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 1524161

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention