BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS

    MDR report key: 4092847 · Received September 16, 2014

    Report

    Report Number
    2017233-2014-00475
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    July 28, 2014
    Report Date
    September 16, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE LOT MET RELEASE REQUIREMENTS. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING. REFER TO MEDWATCH #2017233-2014-00474 FOR OTHER DEVICE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE: DEVICE MANUFACTURE DATE = 06/18/2014.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GORE THE PATIENT PRESENTED 12 DAYS POST IMPLANT, OF THE GORE VIABAHN® ENDOPROSTHESIS, WITH THROMBOSIS. THE PATIENT WAS LYSED OVERNIGHT AND THE THROMBOSIS WAS REMOVED INTERVENTIONALLY THE FOLLOWING DAY. THE DEVICE REMAINS IN THE PATIENT AND IS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571733 GORE VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES 12755110

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention