BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 952416 · Received November 20, 2007

    Report

    Report Number
    2017233-2007-00395
    Event Type
    Death
    Date Received
    November 20, 2007
    Date of Event
    June 27, 2007
    Report Date
    November 20, 2007
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON OCTOBER 22, 2007 A VOLUNTARY MEDWATCH WAS REC'D (DATED OCTOBER 16, 2007) FROM THE FDA INFORMING GORE OF AN EVENT REPORTED FROM A THIRD PARTY. ON OCTOBER 29, 2007, A SECOND LETTER WAS REC'D FROM THE FDA (DATED SEPTEMBER 11, 2007) WHICH WAS MATCHED UP TO THE ORIGINAL VOLUNTARY MEDWATCH. IN 2007, THIS PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESIS. AS REPORTED, THIS PT SUFFERED OCCLUSION TO THE LOWER EXTREMITY, MULTIPLE CEREBROVASCULAR INFARCTS AND DEATH. FURTHER INVESTIGATION IS NECESSARY.

    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 05086059

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death