BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1041146 · Received May 12, 2008

    Report

    Report Number
    1820334-2008-00262
    Event Type
    Injury
    Date Received
    May 12, 2008
    Date of Event
    December 16, 2007
    Report Date
    April 25, 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

    EVALUATION: EACH ZENITH PRODUCT IS 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. THE DEVICE REMAINS IMPLANTED AND NO FILMS WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THAT A DISTAL TYPE I ENDOLEAK OCCURRED DUE TO ANATOMICAL CHANGES OVER TIME AND PT ANATOMY.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA REPAIR IN 2006. ONE MAIN BODY GRAFT AND TWO ILIAC LEG GRAFTS WERE PLACED. OVER TIME, A TYPE IB ENDOLEAK DEVELOPED, SO THE PHYSICIAN PLACED TWO MORE ILIAC LEG GRAFTS IN 2007, TO EXTEND THE SEAL IN THE LEFT COMMON ILIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1774320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention