BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ILIAC LEG GRAFT

    MDR report key: 1011897 · Received March 11, 2008

    Report

    Report Number
    1820334-2008-00125
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    January 2, 2008
    Report Date
    February 14, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THAT THIS EVENT OCCURRED DUE TO ANATOMICAL CHANGES OVER TIME AND PT ANATOMY.

    Description of Event or Problem · 1

    A FEMALE PT UNDERWENT INITIAL AAA REPAIR IN 2005. ONE MAIN BODY GRAFT AND TWO ILIAC LEG GRAFTS WERE PLACED. THE PT'S LEFT COMMON ILIAC CONTINUED TO GROW WITH NO ENDOLEAKS NOTED, BUT THE PHYSICIAN DECIDED TO FIX IT. SO IN 2008, THREE MAIN BODY EXTENSION GRAFTS WERE PLACED. THERE WAS A LANDING ZONE JUST ABOVE THE INTERNAL ILIAC BECAUSE THE INITIAL ILIAC LEG GRAFT WAS PLACED A LITTLE HIGH, SO THE PHYSICIAN USED THE CUFFS TO EXTEND DOWN JUST ABOVE THE INTERNAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ILIAC LEG GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 1532147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other