BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1425976 · Received July 31, 2009

    Report

    Report Number
    2017233-2009-00396
    Event Type
    Injury
    Date Received
    July 31, 2009
    Date of Event
    May 31, 2009
    Report Date
    July 31, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING AND STERILIZATION PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING AND STERILIZATION PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ATTEMPTS TO ACQUIRE INFORMATION REQUIRED FOR THIS FORM WERE MADE BY GORE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. ALSO IMPLANTED IN THE PT WERE: PXC 181200. PXC181200.

    Description of Event or Problem · 1

    IN 2008, THE PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IN 2009, THE PT DEVELOPED A SEPTICEMIA CAUSED BY A URINARY-TRACT INFECTION. ON THE FOLLOWING MONTH, A COMPUTED TOMOGRAPHY IMAGE SHOWED THAT A PART OF THE AORTIC ANEURYSM WAS PROMINENT. SO THE PHYSICIAN BELIEVED THAT THE ANEURYSMAL SAC AND THE IMPLANTED EXCLUDER HAD BEEN ALREADY INFECTED. FOUR DAYS LATER, THE PHYSICIAN DECIDED TO MONITOR THE PT. ON THE FOLLOWING MONTH, THE PT WAS CONVERTED TO THE OPEN REPAIR SURGERY AND THE VASCULAR RECONSTRUCTION WAS PERFORMED. THE AORTA-ILIAC BYPASS WAS MADE USING A SAPHENOUS VEIN. THEN, THE FEMORAL-FEMORAL CROSSOVER BYPASS WAS MADE USING THE OTHER SAPHENOUS VEIN. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURSYM TREATMENT MIH W.L. GORE & ASSOCIATES WLG325 06359447

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR