BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1912701 · Received November 24, 2010

    Report

    Report Number
    2017233-2010-00525
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 23, 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) 2010, A (B)(6) MALE PT WAS IMPLANTED WITH AN INTERPOSITION GORE PROPATEN VASCULAR GRAFT IN A BYPASS PROCEDURE FOR A POPLITEAL ANEURYSM. IT WAS REPORTED TO GORE THAT THE GRAFT WAS LEAKING SEROUS FLUID AT TWO WEEKS POST-OP. IT WAS REPORTED THAT THE PHYSICIAN CANNOT TELL FOR SURE WHETHER THE GRAFT WAS INFECTED. THE GRAFT WAS EXPLANTED ON (B)(6) 2010. THE GRAFT IS NOT BEING RETURNED TO GORE FOR EVALUATION.

    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 77 YR Required Intervention