BEUDAMED
    FDA Adverse Event Other Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 1050159 · Received May 23, 2008

    Report

    Report Number
    2017233-2008-00285
    Event Type
    Other
    Date Received
    May 23, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 22, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS 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

    THE PT PRESENTED WITH STENOTIC LESION OF THE SFA. THE PT HAD 2 VESSEL RUN-OFF, NO CLOTTING ISSUES AND WAS ON ASPIRIN AND PLAVIX. IN 2008, THREE VIABAHN DEVICES WITH HEPARIN COATING WERE IMPLANTED. TWO DAYS LATER, THE PT REPORTED PAIN IN THE THIGH. THE PHYSICIAN DID NOT SUSPECT CLOTTING OF THE DEVICES. FIVE DAYS LATER, THE PHYSICIAN CONFIRMED DEVICE THROMBOSIS. NO RE-INTERVENTION WAS PERFORMED. THE PT AGAIN EXPERIENCED PRE-PROCEDURE SYMPTOMS AND WILL BE TREATED MEDICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIABAHN ENDOPROSTHESIS NONE NIP W.L. GORE & ASSOCIATES,INC WLG335 05629369

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other