BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1249802 · Received December 2, 2008

    Report

    Report Number
    2953161-2008-00404
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 4, 2008
    Report Date
    December 1, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICE IMPLANTED: PC141400/02414116.

    Description of Event or Problem · 1

    IN 2003, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. CONTROL CT (UNKNOWN DATE) SHOWED A GROWING ANEURYSM WITHOUT A DETECTABLE CAUSE. IN 2008, THE PATIENT WENT FOR SURGERY, AND THE TWO GORE EXCLUDER AAA ENDOPROSTHESES WERE EXPLANTED, AND REPLACED BY A GORE SBT PROTHESIS. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 013231105

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention