BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1033864 · Received April 25, 2008

    Report

    Report Number
    1820334-2008-00230
    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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: COOK'S INSTRUCTIONS FOR USE DOES INDICATE THAT THE LONG-TERM PERFORMANCE OF THE ENDOVASCULAR GRAFTS HAS NOT YET BEEN ESTABLISHED. ALL PTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR F/U TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED F/U. THE DEVICE REMAINS IMPLANTED AND NO FILMS WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THAT A TYPE I AND TYPE II ENDOLEAK WERE PRESENT, DUE TO PT ANATOMY AND ANATOMICAL CHANGES OVER TIME.

    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. THE RIGHT ILIAC LIMB WAS RIGHT AT THE HYPOGASTRIC, AND IT HAD SEALED IN AN ILIAC ANEURYSM. HOWEVER, OVER TIME THE ILIAC ANEURYSM GREW AND THE AAA SAC BECAME PULSATILE. THE PHYSICIAN COULD NOT SEE ANY CONTRAST FILLING THE SAC, BUT COULD SEE A LITTLE AROUND THE LIMB. IN 2008, THE PHYSICIAN EXTENDED THE LIMB BY PLACING ANOTHER ILIAC GRAFT AS WELL AS COIL EMBOLIZED A LUMBAR AND THE HYPOGASTRIC. AFTER EXTENDING THE ILIAC LEG, THIS SEALED AND THE AAA SAC WAS NO LONGER PULSATILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1687723

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention