BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1772164 · Received July 23, 2010

    Report

    Report Number
    2017233-2010-00348
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    October 12, 2007
    Report Date
    July 22, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007, A (B)(6) FEMALE PATIENT WAS IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT IN AN A-V ACCESS PROCEDURE FROM THE RADIAL ARTERY TO THE MEDIAN CUBITAL VEIN. ON (B)(6) 2007, THE PATIENT PRESENTED WITH THROMBOSIS WITHOUT STENOSIS. A THROMBECTOMY PROCEDURE WAS PERFORMED.

    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 66 YR Required Intervention