BEUDAMED
    FDA Adverse Event Summary report: N

    GORE-TEX VASCULAR GRAFT

    MDR report key: 953263 · Received November 13, 2007

    Report

    Report Number
    2017233-2007-00373
    Date Received
    November 13, 2007
    Report Date
    November 12, 2007
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    FIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE IS UNKNOWN; HOWEVER, THE IMPLANT DURATION WAS 3.5 YRS. DEVICE EVALUATION ANTICIPATED, BUT NOT YET COMPLETED. THE INVESTIGATION IS PRESENTLY IN PROGRESS.

    Description of Event or Problem · 1

    AS REPORTED, THE AV ACCESS PT RECEIVED A 6MM GORE-TEX VASCULAR GRAFT IN THE LEFT ARM. APPROX 3.5 YRS POST IMPLANT, THE PT EXPERIENCED EDEMA AT THE GRAFT LOCATION. THE PHYSICIAN EXPLANTED THE GRAFT AND RETURNED THE GRAFT FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX VASCULAR GRAFT VASCULAR PROSTHESIS FIQ W.L. GORE & ASSOCIATES, INC WLG250

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention