BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINWALLED FEP RINGED GORE-TEX VASCULAR GRAFT

    MDR report key: 949131 · Received November 16, 2007

    Report

    Report Number
    2017233-2007-00389
    Event Type
    Injury
    Date Received
    November 16, 2007
    Date of Event
    January 1, 1995
    Report Date
    November 16, 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 UNKNOWN. THE IMPLANT DATE REMAINS UNKNOWN. SEMOTOWKA 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, AN AXILLOBIFEMORAL BYPASS PROCEDURE WAS PERFORMED FOR THE TREATMENT OF SEVERE AORTOILIAC DISEASE. THE OPERATION AND POSTOPERATIVE COURSE WERE UNEVENTFUL. THREE WEEKS POST IMPLANT, THE PATIENT DEVELOPED COMPLICATIONS WHICH INCLUDED LEFT INFRACLAVICULAR PAIN AND SWELLING. THE PATIENT WAS TAKEN INTO SURGERY AND THE INFRACLAVICULAR REGION WAS EXPLORED. IT WAS NOTED THAT THE RING OF THE GRAFT REMAINED SUTURED TO THE AXILLARY ARTERY AND THE GRAFT ITSELF DISRUPTED JUST DISTAL TO THE SUTURE LINE. AN INTERPOSITION GRAFT WAS PLACED BETWEEN THE SUBCLAVIAN ARTERY AND THE DISRUPTED SEGMENT OF THE ORIGINAL GRAFT. CULTURES OBTAINED FROM THE ANASTOMOTIC SITE WERE NEGATIVE. THE PATIENT HAD AN UNEVENTFUL POSTOPERATIVE COURSE AND WAS DISCHARGED.

    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 62 YR Life Threatening