BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINWALLED FEP RINGED GORE-TEX VASCULAR GRAFT

    MDR report key: 951492 · Received November 19, 2007

    Report

    Report Number
    2017233-2007-00392
    Event Type
    Injury
    Date Received
    November 19, 2007
    Date of Event
    January 1, 1995
    Report Date
    November 19, 2007
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    PMA / PMN Number
    K881732
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT # IS UNK. THE IMPLANT DATE REMAINS UNK. SAMOTOWKA M, KAHN MB, ROBERTS AB, BAKSHI KR, FAIRMAN RM. THIN-WALLED POLYTETRAFLUOROETHYLENE GRAFT FAILURE IS A CAUSE OF AXILLARY PULLOUT SYNDROME. SURGERY 1995; 117:113-4.

    Description of Event or Problem · 1

    VIA SCIENTIFIC LITERATURE, THE PT PRESENTED WITH A BILATERAL EXTERNAL ILIAC ARTERY OCCLUSIONS AND A LEFT SUPERFICIAL FEMORAL ARTERY OCCLUSION. A LEFT AXILLOPROFUNDA BYPASS WAS PERFORMED. THE POSTOPERATIVE COURSE WAS UNEVENTFUL AND THE PT WAS DISCHARGED. THREE WEEKS POST PROCEDURE, THE PT DEVELOPED AN INFRACLAVICULAR PULSATILE MASS. AT OPERATION, IT WAS FOUND THAT THE GRAFT HAD RIPPED AND THAT THE SUTURE WAS INTACT ON THE ARTERY. AN INTERPOSITION GRAFT WAS PLACED. INTRAOPERATIVE CULTURES WERE NEGATIVE. THE PT HAD AN UNEVENTFUL POSTOPERATIVE COURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINWALLED FEP RINGED GORE-TEX VASCULAR GRAFT VASCULAR PROSTHESIS DSY W.L. GORE & ASSOCIATES, INC. WLG401 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening