BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX VASCULAR GRAFT

    MDR report key: 1931043 · Received December 8, 2010

    Report

    Report Number
    2017233-2010-00547
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 9, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K802095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL ANTICIPATED, BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT WAS IMPLANTED WITH A GORE-TEX VASCULAR GRAFT IN THE ABDOMEN. IT WAS REPORTED TO GORE THAT THE PT EXPERIENCED PERSISTENT SEROMA. AFTER GRAFT PLACEMENT, THE PT HAD TO CONTINUALLY RETURN TO HAVE THE FLUID DRAINED. IT WAS REPORTED TO BE UP TO 300CC'S PER WEEK. ON (B)(6) 2010, THE GRAFT WAS EXPLANTED AND REPLACED WITH A DACRON GRAFT AND IS BEING RETURNED TO GORE FOR EVAL.

    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 WLG200

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention