BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINWALL FEPRINGEDGORE - TEXVASCGRAFT W/REMRINGS

    MDR report key: 780004 · Received November 10, 2006

    Report

    Report Number
    2017233-2006-00322
    Event Type
    Injury
    Date Received
    November 10, 2006
    Date of Event
    August 22, 2006
    Report Date
    November 10, 2006
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DISPOSITION OF THE EXPLANTED GRAFT IS UNKNOWN; THUS, IT IS NOT AVAILABLE FOR EXAMINATION. THE REVIEW OF THE MANUFACTURING AND TESTING RECORDS, SPECIFICALLY THE STERILIZATION RECORDS VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    A THIN WALLED FEP RINGED GORE-TEX VASCULAR GRAFT WITH REMOVABLE RINGS WAS IMPLANTED AS AN ILIO-FEMORAL BYPASS FOR THE REPAIR OF AN ILIO-FEMORAL ANEURYSM. APPROXIMATELY 5 MONTHS POST-OPERATIVELY, THE PATIENT PRESENTED WITH SIGNS OF SEPTIC SHOCK. THE PT WAS TRANSFERRED TO A DIFFERENT HOSPITAL FOR EXPLANTATION OF THE GRAFT AND IMPLANTATION OF A HOMOGRAFT. BLOOD CULTURES TAKEN WERE POSITIVE FOR MYCOBACTERIUM FORTUITUM. THE PT WAS DISCHARGED FROM THE HOSPITAL WITH ANTIBIOTIC THERAPY AND AS OF THIS REPORT IS DOING FINE. DISPOSITION OF THE EXPLANTED GRAFT IS UNKNOWN; THUS, IT IS NOT AVAILABLE FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINWALL FEPRINGEDGORE - TEXVASCGRAFT W/REMRINGS EPTFE VASCULAR PROSTHESIS DSY W.L. GORE & ASSOCIATES WLG401 03665938

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention