BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX VASCULAR GRAFT

    MDR report key: 1618691 · Received February 24, 2010

    Report

    Report Number
    2017233-2010-00085
    Event Type
    Injury
    Date Received
    February 24, 2010
    Date of Event
    January 8, 2009
    Report Date
    February 24, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DYF
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2004, PT WAS IMPLANTED WITH A 6MM GORE-TEX GRAFT. AN AV ACCESS WAS CREATED FROM LEFT BRACHIAL ARTERY TO MEDIAN CUBITAL VEIN. ON (B) (6) 2004, GRAFT WAS DECLOTTED, WITH REVISION OF MID-PORTION OF A-V GRAFT. ON (B) (6) 2004, A DECLOT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX VASCULAR GRAFT DYF/PROSTHESIS, VASCULAR GRAFT, OF LESS THAN 6MM DIAMETER DYF W.L. GORE & ASSOCIATES WLG250

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention