BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1972242 · Received January 20, 2011

    Report

    Report Number
    2017233-2011-00030
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    September 1, 2009
    Report Date
    January 19, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, A GORE PROPATEN VASCULAR GRAFT WAS IMPLANTED IN A BELOW-KNEE FEMORAL TO POPLITEAL BYPASS PROCEDURE. INDICATION FOR BYPASS WAS ACUTE ISCHEMIA DUE TO A GRAFT FAILURE. A RIGHT BELOW-KNEE AMPUTATION WAS DONE ON (B)(6) 2009.

    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 60 YR Required Intervention