BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIATORR TIPS ENDOPROSTHESIS

    MDR report key: 3231721 · Received July 10, 2013

    Report

    Report Number
    3007284313-2013-00057
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    June 20, 2013
    Manufacturer
    W. L. GORE ASSOCIATES
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICES COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER REMAINS UNK. THE DEVICE REMAINS IMPLANTED IN THE PT THEREFORE AN ENGINEERING INVESTIGATION COULD NOT BE PERFORMED. DATE OF PROCEDURE IS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS IMPLANTING A GORE VIATORR TIPS ENDOPROSTHESIS IN A PT WITH PERISTOMAL BLEEDING. A DIRECT INTRAHEPATIC PORTOSYSTEMIC SHUNT METHOD WAS UTILIZED BECAUSE THE RIGHT HEPATIC VEIN BRANCHED SUPERIORLY FROM THE INFERIOR VENA CAVA, INSTEAD OF INFERIORLY WHICH WOULD HAVE MADE THE TRADITIONAL TIPS TRANSJUGULAR APPROACH ANATOMICALLY DIFFICULT. FIRST, AN 8MM BARE METAL STENT WAS DEPLOYED. THEN, A 10MM VIATORR DEVICE WAS ADVANCED INTO THE BARE METAL STENT AND DEPLOYED BEING CONSTRAINED TO 8MM BY THE OUTER STENT. WITHIN A WEEK AFTER THE ORIGINAL PROCEDURE A REVISION PROCEDURE WAS PERFORMED TO TREAT A THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319092 GORE VIATORR TIPS ENDOPROSTHESIS MIR W. L. GORE ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INTRODUCER SHEATH| FLUOROSCOPY