BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1013107 · Received March 14, 2008

    Report

    Report Number
    2017233-2008-00099
    Event Type
    Death
    Date Received
    March 14, 2008
    Date of Event
    February 9, 2008
    Report Date
    March 13, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT HIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE: ATTACHED ADDITIONAL DEVICE IMPLANTED IN THIS PATIENT AND INVOLVED IN THIS EVENT IS GORE TAG THORACIC ENDOPROSTHESIS TG3420/05646396.

    Description of Event or Problem · 1

    IN 2008, A PATIENT HAD REPAIR OF AN ABDOMINAL AORTIC ANEURYSM, THORACIC AORTIC ANEURYSM, SUPERIOR MESENTERIC ARTERY ANEURYSM, AND RIGHT COMMON ILIAC ARTERY ANEURYSM WITH A GORE TAG THORACIC ENDOPROSTHESIS, GORE EXCLUDER AAA ENDOPROSTHESIS, AND FLUENCY STENTS. POST-OPERATIVELY, THE PATIENT DEVELOPED PARALYSIS OF THE LOWER EXTREMITIES. THE PATIENT HAD GONE INTO RENAL FAILURE AND NEVER REGAINED FUNCTION IN HIS LOWER EXTREMITIES. THE PATIENT EXPIRED ON EIGHT DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES,INC WLG325 05626328

    Patients

    Seq Age Sex Outcome Treatment
    1 Death