BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE-TEX SUTURE

    MDR report key: 92861 · Received May 20, 1997

    Report

    Report Number
    2017233-1997-00015
    Event Type
    Death
    Date Received
    May 20, 1997
    Date of Event
    April 1, 1997
    Report Date
    May 20, 1997
    Manufacturer
    W.L. GORE & ASSOC., INC.
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON SECURED A DUAL MESH PROSTHESIS FOR A LARGE VENTRAL HERNIA REPAIR WITH CV-O GORE-TEX SUTURE. APPROXIMATELY A WEEK AND A HALF LATER, THE PATIENT MANIFESTED AN INTESTINAL OBSTRUCTION AND A SECOND SURGERY WAS PERFORMED. THE SECOND SURGERY REVEALED DISRUPTION OF THE SUTURES FROM THE INITIAL PROCEDURE. THE PATIENT DIED DURING THE SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE Implant NONABSORBABLE SUTURE GAW W.L. GORE & ASSOC., INC. WLG600 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| L| R DUAL MESH