BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1120863 · Received August 15, 2008

    Report

    Report Number
    2017233-2008-00459
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 17, 2008
    Report Date
    August 14, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PATIENT WAS DIAGNOSED WITH METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION.

    Description of Event or Problem · 1

    A MALE WAS IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT IN THE LEFT FEMORAL POPLITEAL POSITION. THE GRAFT WAS EXPLANTED IN 2008. PHYSICIAN SUSPECTED THAT THE GRAFT POSSIBLY COULD BE INFECTED WITH MRSA. THERE WAS FLUID AROUND THE GRAFT OF WHICH A BIOPSY WAS TAKEN. THERE WAS NO INFECTION INDICATED IN THE BIOPSY BUT BECAUSE THE PATIENT HAD BEEN ON VANCOMYCIN FOR A FEW DAYS, THE RESULTS WERE INCONCLUSIVE. THE PHYSICIAN REPLACED THE GORE PROPATEN VASCULAR GRAFT WITH VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT NONE DSY W.L. GORE & ASSOCIATES WLG450 2143179PP016

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention