BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH AAA ILIAC LEG DELIVERY SYSTEM

    MDR report key: 1060559 · Received June 12, 2008

    Report

    Report Number
    1820334-2008-00294
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    April 3, 2008
    Report Date
    May 13, 2008
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING THE MAIN BODY GRAFT WIRE AND SHEATH ASSEMBLY TO INTRODUCE THE IPSILATERAL ILIAC LEG GRAFT, WHEN WITHDRAWING BOTH, THE ILIAC LEG SHEATH BROKE NEXT TO THE VALVE OF THE ILIAC LEG. ADDITIONAL INFO RECEIVED ON 5/15/08 - WHEN THEY DEPLOYED THE IPSILATERAL LEG, THEY WERE PULLING BACK WITH BOTH INTRODUCERS, ILIAC AND MAIN BODY AND THE SHEATH OF THE ILIAC LEG BROKE. THE SHEATH TUBING OF THE ILIAC LEG SEPARATED FROM THE VALVE ASSEMBLY. THE PT'S ANATOMY MAY HAVE BEEN A FACTOR, BUT NOT SURE. THEY WERE ABLE TO REMOVE THE DEVICE AND DEPLOY A NEW ILIAC LEG. PT OUTCOME WAS FINE, NO BLEEDING ISSUES.

    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 2034588

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR