BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1033873 · Received April 25, 2008

    Report

    Report Number
    1820334-2008-00240
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: ZENITH DEVICES ARE EACH SHIPPED WITH AN INSTRUCTIONS FOR USE (IFU) BOOKLET THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU ALSO ADVISES ON APPROPRIATE FOLLOW-UP SO THAT LEAKS, SHOULD THEY OCCUR, CAN BE IDENTIFIED AND ADDRESSED BEFORE CAUSING CLINICAL PROBLEMS. AN INTERNAL CLINICAL REVIEW INDICATED THAT THE EVENT WAS CAUSED BY ANATOMICAL CHANGES OVER TIME. THE DEVICE REMAINS IMPLANTED AND NO FILMS WERE PROVIDED TO ASSIST IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA REPAIR IN 2004. ONE MAIN BODY GRAFT, TWO ILIAC LEG GRAFTS, AND ONE LEG EXTENSION GRAFT WERE PLACED. THE PHYSICIAN WAS AWARE DURING THE FIRST PROCEDURE THAT THE LEFT ILIAC LEG GRAFT MAY NOT SEAL DUE TO THE LARGE DIAMETER OF THE PATIENT'S ILIAC ARTERY. AT THAT TIME, THE PHYSICIAN DECIDED NOT TO EXTEND THE GRAFT INTO THE EXTERNAL ILIAC, THUS COVERING THE INTERNAL ILIAC. INSTEAD, HE DECIDED TO MONITOR THE SIZE OF THE ILIAC AND THE AAA WITH FOLLOW-UP CT SCANS OVER SEVERAL MONTHS. THE CT SCANS REVEALED THE ILIAC AND AAA WERE CONTINUING TO GROW. THERE WAS A TYPE I ENDOLEAK. THEREFORE, THE PHYSICIAN DECIDED TO EMBOLIZE THE INTERNAL ILIAC AND THEN EXTEND THE GRAFT INTO THE EXTERNAL ILIAC BY PLACING ANOTHER ILIAC LEG GRAFT TO PREVENT RETROGRADE FLOW INTO THE ILIAC AND AAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1403507

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention