BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE

    MDR report key: 111623 · Received August 8, 1997

    Report

    Report Number
    2017233-1997-00021
    Event Type
    Injury
    Date Received
    August 8, 1997
    Date of Event
    May 31, 1997
    Report Date
    August 8, 1997
    Manufacturer
    W.L. GORE & ASSOC., INC.
    Product Code
    DTH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 5/16/97, THE SURGEON PERFORMED A LUMBAR SPIME THETER RELEASE, SECURING A PRECLUDE DURA SUBSTITUTE GRAFT WITH CV-4 GORE-TEX SUTURE. THE PT DEVELOPED AN INFECTION REQUIRING A REOPERATION FOR EVACUATION OF THE ABCESS WITH PLACEMENT OF A LUMBAR DRAIN ON 5/26/97. ON 5/31/97, DESPITE ANTIBIOTIC THERAPY, WITH PERSISTENT CEREBROSPINAL FLUID LEAKAGE AND PERSISTENTLY POSITIVE CEREBROSPINAL FLUID CULTURES, THE SURGEON REPLACED THE GRAFT WITH CADAVERIC DURA. FOLLOWING THE FINAL OPERATION, WITH AGGRESSIVE CEREBROSPINAL DRAINAGE, THE PT HAS PERSISTENTLY NEGATIVE CEREBROSPINAL FLUID CULTURES AND HIS WOUND REMAINED DRY. POSTOP DAY 21, THE PT WAS DISCHARGED TO HOME WITH AN ADD'L TWO WEEKS OF ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE Implant NONABSORBABLE SUTURE DTH W.L. GORE & ASSOC., INC. WLG604 9330C40

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R PRECLUDE DURA SUBSTITUTE| ITEM # 1PDM303.
    2