BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE

    MDR report key: 899927 · Received August 20, 2007

    Report

    Report Number
    MW5003475
    Event Type
    Death
    Date Received
    August 20, 2007
    Date of Event
    June 27, 2007
    Report Date
    August 19, 2007
    Manufacturer
    GORE MEDICAL
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A STENTED GRAFT IMPLANT AT ABDOMINAL AORTIC ANEURYSM USING THREE GORE BRAND EXCLUDER AAA ENDOPROSTHESIS PARTS, CATALOG NUMBER PXL 161007, LOT 03469596; CATALOG NUMBER PXT 261412, LOT 05086059; CATALOG NUMBER PXC 141000, LOT 05025733. OCCLUSION TO LOWER EXTREMITY; MULTIPLE CEREBROVASCULAR INFARCTS. DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE BIFURCATED STENT MIH GORE MEDICAL AAA EXCLUDER 05086059
    2 GORE BIFURCATED STENT MIH GORE MEDICAL AAA EXCLUDER 03469596
    3 GORE BIFURCATED STENT MIH GORE MEDICAL AAA EXCLUDER 05025733

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death| H