BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX VASCULAR GRAFT (TAPERED)

    MDR report key: 1081760 · Received July 25, 2008

    Report

    Report Number
    2017233-2008-00412
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 25, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    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, VIETH 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 & ASSOC, INC, FLAGSTAFF, ARIZ) GRAFT. SHE DEVELOPED A GRAFT SEROMA 1 MO FOLLOWING PLACEMENT OF THE GRAFT AND WAS UNSUCCESSFULLY MANAGED WITH BOTH PERCUTANEOUS AND OPEN DRAINAGE OF THE SEROMA. TRANSUDATION OF FLUID WAS SEEN EMANATING FROM THE ATRIAL END OF THE PTFE GRAFT. AN 8 MM X 50 MM WALL GRAFT (BOSTON SCIENTIFIC, NATICK MASS) WAS PERCUTANEOUSLY DEPLOYED IN THE ATRIAL PORTION OF THE GRAFT. THE SEROMA COMPLETELY RESOLVED IN 2 WEEKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention