BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1033857 · Received April 25, 2008

    Report

    Report Number
    1820334-2008-00231
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: ZENITH DEVICES ARE EACH SHIPPED WITH AN INSTRUCTIONS FOR USE BOOKLET THAT LISTS THE ANATOMICAL REQUIREMENTS, WARNINGS, PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU ALSO ADVISES ON APPROPRIATE F/U 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 THE EVENT WAS A RESULT OF PT ANATOMY AND POSSIBLY ANATOMICAL CHANGES OVER TIME.

    Description of Event or Problem · 1

    A MALE UNDERWENT INITIAL AAA REPAIR IN 2007. ONE FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. THE ILIAC WAS A LITTLE TORTUOUS AND HAD ULCER-LIKE PATCHES AT THE SEAL ZONE. A DISTAL TYPE I ENDOLEAK DEVELOPED, SO IN 2008, THE PHYSICIAN PLACED ANOTHER ILIAC LEG GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1814390

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention