BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1201469 · Received October 17, 2008

    Report

    Report Number
    2017233-2008-00758
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    October 1, 2007
    Report Date
    October 16, 2007
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED BECAUSE THE DEVICE SERIAL NUMBER WAS NOT AVAILABLE. RESULTS - THERE ARE NO MFG EVAL RESULTS BECAUSE THE DEVICE SERIAL NUMBER WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    IN 2007, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. APPROX THREE MONTHS LATER, THE AORTA RUPTURED, AND A COOK ENDOVASCULAR DEVICE WAS IMPLANTED OVERLAPPING PROXIMALLY WITH THE TRUNK IPSILATERAL LEG COMPONENT. IN APPROX TWO MONTHS LATER, ALL THE ENDOVASCULAR DEVICES WERE EXPLANTED DUE TO INFECTION AND REPLACED WITH A HOMOGRAFT. THE PT IS STABLE AND NO LONGER HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG325

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R| S