BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA MAIN BODY GRAFT

    MDR report key: 1003275 · Received February 27, 2008

    Report

    Report Number
    1820334-2008-00083
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    September 1, 2004
    Report Date
    January 28, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST WITH OUR INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THAT THE EVENT WAS THE RESULT OF PATIENT ANATOMY AND/OR INCORRECT SIZING AND PLANNING.

    Description of Event or Problem · 1

    A FEMALE UNDERWENT AAA REPAIR IN 2004. ONE ZENITH MAIN BODY GRAFT AND ONE ILIAC LEG GRAFT WERE PLACED AS WELL AS TWO COMPONENTS OF ANOTHER MANUFACTURER. POST-OP IMAGES SHOWED A PROXIMAL TYPE I ENDOLEAK. ABOUT 5 DAYS LATER, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE. ANOTHER MANUFACTURER'S STENT GRAFT WAS PLACED TO REPAIR THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA MAIN BODY GRAFT MIH ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1385531

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention