BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1912696 · Received November 24, 2010

    Report

    Report Number
    2017233-2010-00526
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    April 13, 2007
    Report Date
    November 23, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007, AN 8MM GORE PROPATEN VASCULAR GRAFT WAS IMPLANTED IN A BYPASS PROCEDURE. THE IMPLANT WAS IN THE PT'S LEFT LEG, FROM THE COMMON FEMORAL TO POPLITEAL ARTERY. ON (B)(6) 2007, A REVISION WAS REQUIRED BECAUSE THE PT "DEVELOPED AV FISTULA AT DISTAL ANASTOMOSIS". THE GRAFT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W.L. GORE & ASSOCIATES WLG450

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR