BEUDAMED
    FDA Adverse Event Death Summary report: N

    THIN WALLED FEP RINGED GORE-TEX VASCULAR GRAFT W/REM RINGS

    MDR report key: 519348 · Received April 5, 2004

    Report

    Report Number
    2017233-2004-00001
    Event Type
    Death
    Date Received
    April 5, 2004
    Date of Event
    May 22, 2003
    Report Date
    April 1, 2004
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE GRAFT WAS PLACED AS AN EXILLO-FEMORAL BYPASS. FOUR DAYS POSTOPERATIVELY, A GRAFT DISRUPTION WAS DETECTED, NOT AT THE VESSEL-TO-GRAFT ANASTOMOSIS. SIXTEEN DAYS LATER, THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THIN WALLED FEP RINGED GORE-TEX VASCULAR GRAFT W/REM RINGS VASCULAR PROSTHESIS DSY W.L. GORE & ASSOCIATES WLG401 01264332

    Patients

    Seq Age Sex Outcome Treatment
    1 *