BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT (LINED)

    MDR report key: 1332910 · Received February 27, 2009

    Report

    Report Number
    2017233-2009-00117
    Event Type
    Injury
    Date Received
    February 27, 2009
    Report Date
    February 27, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INOUE Y, SUGANO N, JIBIKI M, ET AL. CUFFED ANASTOMOSIS FOR ABOVE-KNEE FEMOROPOPLITEAL BYPASS WITH A STRETCH EXPANDED POLYTETRAFLUOROETHYLENE GRAFT. SURGERY TODAY 2008; 38: 679-684.

    Description of Event or Problem · 1

    IN THE MEDICAL LITERATURE, IT WAS REPORTED THAT IN 2005, A PATIENT WAS IMPLANTED WITH A 6MM THIN-WALLED FEP RINGED GORE-TEX STRETCH VASCULAR GRAFTS AS AN ABOVE-KNEE FEMERO-POPLITEAL BYPASS PROCEDURE. IT WAS REPORTED THAT THERE WAS A GRAFT INFECTION WITHIN 11 MONTHS AFTER IMPLANTATION. THE PATIENT COULD NOT UNDERGO REOPERATION BECAUSE THEY WERE AT HIGH RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT (LINED) NONE DSY W.L. GORE & ASSOCIATES,INC WLG402

    Patients

    Seq Age Sex Outcome Treatment
    1 Other