BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1033871 · Received April 25, 2008

    Report

    Report Number
    1820334-2008-00234
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: COOK DOES ADVISE IN THE INSTRUCTIONS FOR USE TO CONFIRM POSITION OF THE DISTAL END OF THE ILIAC LEG GRAFT. REPOSITION THE ILIAC LEG GRAFT IF NECESSARY TO ENSURE BOTH THE INTERNAL ILIAC PATENCY AND A MINIMUM OVERLAP OF ONE FULL ILIAC LEG STENT WITHIN THE MAIN BODY ENDOVASCULAR GRAFT. INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION, OR INADVERTENT OCCLUSION OF THE RENAL, OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS. THE DEVICE REMAINS IMPLANTED AND NO FILMS WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THAT THERE WAS A TYPE I ENDOLEAK DUE TO PT ANATOMY.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA REPAIR IN 2004. ON MAIN BODY GRAFT, TWO ILIAC LEG GRAFTS, AND TWO MAIN BODY EXTENSION GRAFTS WERE PLACED. THE PHYSICIAN PLACED MAIN BODY EXTENSIONS INSIDE THE LEFT LIMB IN ORDER TO TRY TO PRESERVE THE HYPOGASTRIC. HOWEVER, UPON F/U THERE WAS A TYPE IB ENDOLEAK, SO TWO MORE ILIAC LEG GRAFTS WERE PLACED, EXTENDING SEAL ZONE TO THE EXTERNAL. OVER TIME, DUE TO PT'S TORTUOUS ANATOMY AND A MINIMAL OVERLAP CAUSED A LIMB SEPARATION ON THE RIGHT SIDE. THE PHYSICIAN PLACED ANOTHER ILIAC LEG IN 2008 AS A BRIDGE WITH GREAT SUCCESS. (SEE ALSO 1820334-2008-00236).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1399803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention