BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX VASCULAR GRAFT

    MDR report key: 2071839 · Received April 21, 2011

    Report

    Report Number
    2017233-2011-00205
    Event Type
    Injury
    Date Received
    April 21, 2011
    Report Date
    April 20, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT INFORMATION WAS OBTAINED FROM THE FOLLOWING ARTICLE: SUBRAMANIAN K, HASSOUNA A, BAHAL V, WALTER D. PSEUDO ANEURYSM OF A 21 YEAR OLD EPTFE FEMORO-FEMORAL CROSSOVER GRAFT: SUCCESSFUL ENDOVASCULAR REPAIR USING AN EPTFE LINED NITINOL STENT GRAFT. PERSPECTIVES IN VASCULAR SURGERY & ENDOVASCULAR THERAPY 2010;22(4):250-253.

    Description of Event or Problem · 1

    AS STATED IN LITERATURE ARTICLE, THAT AN (B)(6) WOMAN WHO WAS IMPLANTED WITH A 10MM GORE-TEX VASCULAR GRAFT IN A FEMORO-FEMORAL CROSS-OVER BYPASS PROCEDURE IN (B)(6) 1989, PRESENTED 21 YEARS ALTER WITH A RIGHT GROIN LUMP. A PSEUDOANEURYSM WAS LOCATED IN THE GRAFT PROXIMAL TO THE DISTAL ANASTOMOSIS. THE GRAFT WAS WIDELY PATENT. THE PATIENT WAS TREATED ENDOVASCULARLY WITH A 13MM X 8CM GORE VIABAHN ENDOPROSTHESIS TO COVER THE PSEUDOANEURYSM. THE RESULTS WERE EXCELLENT AND SHOWED RESOLUTION OF THE PSEUDOANEURYSM WITH GOOD FLOW THROUGH THE GRAFT AND DISTAL VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TEX VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W.L. GORE & ASSOCIATES, INC WLG200

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention