BEUDAMED
    FDA Adverse Event Other Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1081372 · Received July 23, 2008

    Report

    Report Number
    2017233-2008-00407
    Event Type
    Other
    Date Received
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS CURRENTLY IN PROCESS. THIS EVENT APPEARS TO MEET THE CRITERIA PER THE FDA 5-DAY EVENT NOTICE REGARDING HEPARIN CONTAINING DEVICES ISSUED IN 2008; THEREFORE, GORE IS REPORTING THIS AS A 5-DAY REPORTABLE EVENT.

    Description of Event or Problem · 1

    GORE WAS RECENTLY INFORMED OF A SERIES OF EVENTS WHICH HAVE OCCURRED OVER THE PAST 12 MONTH PERIOD. AFTER THE IMPLANTATION OF A GORE PROPATEN VASCULAR GRAFT, THE PTS REPORTEDLY EXPERIENCED SWELLING OF THE LEG. THESE REPORTS ARE FROM THE SAME HOSP AND SAME PHYSICIAN. THIS IS ALL THE CONFIRMED INFO TO DATE. GORE IS WORKING TO INVESTIGATE AND ASSIGN LOT/ITEM NUMBERS, DATES AND ANY ADD'L INFO TO THESE CLINICAL EVENTS. REFER TO MEDWATCH #: 2017233-2008-00401, -00402, -00403, -00404, -00405, -00406.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT NONE DSY W.L. GORE & ASSOCIATES, INC WLG450 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other