BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT W/THIN LIMBS

    MDR report key: 111606 · Received August 8, 1997

    Report

    Report Number
    2025240-1997-00023
    Event Type
    Injury
    Date Received
    August 8, 1997
    Date of Event
    June 26, 1997
    Report Date
    August 8, 1997
    Manufacturer
    W.L. GORE & ASSOC., INC. (ECHO RIDGE)
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HISTOLOGICAL ANALYSIS OF THE RETURNED BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT AND THE THIN WALLED GORE-TEX STRETCH VASCULAR GRAFT SAMPLES DID NOT CONFIRM PRESENCE OF AN ACTIVE INFECTIOUS PROCESS. NO MICROORGANISMS WERE NOTED, RATHER, IN LOCALIZED REGIONS NEAR THE LEFT LIMB-TO-STRETCH GRAFT EXTENSION ANASTOMOSIS, SOME BACTERIAL DEBIS WAS NOTED WITHIN THE GRAFT WALLS ALONG THE OUTER ASPECT OF BOTH GRAFTS. DEGENERATED CELLS AND PROTEINACEOUS MATERIAL WERE ASSOCIATED WITH THIS REGION. A SIMILAR MATRIX WAS EVIDENT AROUND THE TRUNK PORTION OF THE BIFURCATED GRAFT. THE EVIDENE OF A DEGENERATED PROTEIN MATRIX AROUND THE GRAFT AND LACK OF ADEQUATE HEALING SUGGESTS INVOLVEMENT IN AN ONGOING, LOCALIZED INFECTIOUS PROCESS IN THE SURROUNDING WOUND BED, WHICH WAS LIKELY INTRODUCED DURING THE INITIAL SURGERY. THE REMAINDER OF THE BIFURCATED GRAFT REVEALED A TISSUE RESPONSE CONSISTENT WITH THAT SEEN IN OTHER GORE-TEX VASCULAR GRAFT EXPLANTS OF AN IMPLANT DURATION OF TWO MONTHS. THIS RESPONSE WAS CHARACTERIZED BY TISSUE ATTACHMENT, A SLIGHT FOREIGN BODY RESPONSE, TISSUE INFILTRATION OF THE GRAFT WALL AND A THIN FLOW LINING. GORE-TEX IS A REGISTERED TRADEMARK OF W.L. GORE & ASSOCIATES, INC.

    Description of Event or Problem · 1

    THE GRAFT WAS PLACED AS AN AORTOBIFEMORAL BYPASS. POSTOPERATIVELY, THE PT EXHIBITED CLINICAL SIGNS OF INFECTION. THE LEFT INGUINAL WOUND WAS OPENED AND A PURULENT SUBSTANCE WAS DRAINED. THE WOUND WAS CLEANSED. THE LEFT LIMB OF THE BIFURCATED GRAFT OCCLUDED. AT 2 MOS POSTOPERATIVELY, THE GRAFT WAS REMOVED TO FACILITATE TREATMENT OF THE INFECTION. AT THIS TIME, THE PT IS DOING FINE-POST SEPTICAL STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT W/THIN LIMBS Implant EPTFE VASCULAR PROSTHESIS DSY W.L. GORE & ASSOC., INC. (ECHO RIDGE) WLG302 597043HA00

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention