BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE-TEX SUTURE

    MDR report key: 78650 · Received March 19, 1997

    Report

    Report Number
    2017233-1997-00012
    Event Type
    Death
    Date Received
    March 19, 1997
    Date of Event
    February 16, 1997
    Report Date
    March 19, 1997
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    GAO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    B7- ALL INFO IN THIS ITEM IS BASED ON CORRESPONDENCE WRITTEN BY THE SURGEON AND SUPPLIED TO THE MFR'S REP. H6- (11) UNUSED SUTURE FROM THE SAME LOT WAS RETURNED FROM THE HOSPITAL FOR EVALUATION. H6- (26) STRAIGHT AND KNOTTED TENSILE TESTING WAS PERFORMED ON UNUSED SUTURE RETURNED FROM THE HOSPITAL. H6- (38) VISUAL INSPECTION WAS PERFORMED ON THE UNUSED SUTURE RETURNED FROM THE HOSPITAL. H6- (86) A LOT NUMBER WAS PROVIDED. H6- (708) TENSILE TEST RESULTS AND VISUAL INSPECTIONS ALL MET PRE-RELEASE SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    DR REPAIRED AN ANEURYSM OF THE RIGHT COMMON ILIAC USING AN END TO SIDE ANASTOMOSIS, WITH A 16 X 8 BIFURCATED VASCULAR GRAFT AND SUTURE. PT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY IN RECOVERY. THE PT WENT BACK TO THE OR WHERE IT WAS DISCOVERED THAT THE PROXIMAL SUTURE WAS USED TO REPAIR THE ANASTOMOSIS. PT SUBSEQUENTLY DIED 4 OR 5 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE Implant NONABSORBABLE SUTURE GAO W.L. GORE & ASSOCIATES, INC. CV-3 9615D92

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| H| L| R 16 X 8 BIFURCATED VASCULAR GRAFT