BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX VASCULAR GRAFT (TAPERED)

    MDR report key: 1081763 · Received July 25, 2008

    Report

    Report Number
    2017233-2008-00413
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 25, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NICHOLAS J. GARGIULO NJ III, VEITH FJ, SCHER LA, MD, LIPSITZ EC, SUGGS WD, BENROS RM. EXPERIENCE WITH COVERED STENTS FOR THE MGMT OF HEMODIALYSIS POLYTETRAFLUOROETHYLENE GRAFT SEROMAS. J VASC SURG 2008;48:216-7.

    Description of Event or Problem · 1

    AS REPORTED VIA THE MEDICAL LITERATURE, A FEMALE UNDERWENT RIGHT UPPER EXTREMITY GRAFTING FOR HEMODIALYSIS FROM THE BRACHIAL ARTERY TO THE AXILLARY VEIN USING A STANDARD WALL 4 TO 7 MM TAPERED POLYTETRAFLUOROETHYLENE (PTFE) (W.L. GORE & ASSOCIATES, INC, FLAGSTAFF, ARIZ) GRAFT. SHE DEVELOPED A GRAFT SEROMA AND WAS MANAGED SUCCESSFULLY WITH OPEN DRAINAGE AND PLACEMENT OF A NO 7 JACKSON PRATT DRAIN. TRANSUDATION OF FLUID WAS SEEN EMANATING FROM THE ARTERIAL END OF THE PTFE GRAFT. SIX WEEKS FOLLOWING REMOVAL OF THE DRAIN, THE SEROMA RECURRED. AN 8 MM X 50 MM WALLGRAFT (BOSTON SCIENTIFIC, NATICK, MASS) WAS DEPLOYED IN THE ARTERIAL PORTION OF THE GRAFT RESULTING IN COMPLETE RESOLUTION OF THE SEROMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TEX VASCULAR GRAFT (TAPERED) NONE DSY W.L. GORE & ASSOCIATES WLG211

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention