BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIATORR TIPS ENDOPROSTHESIS

    MDR report key: 3231719 · Received July 10, 2013

    Report

    Report Number
    3007284313-2013-00058
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 13, 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 DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER REMAIN UNK. THE DEVICE REMAINS IMPLANTED IN THE PT THEREFORE AN ENGINEERING INVESTIGATION COULD NOT BE PERFORMED.

    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 AND A HYPERCOAGULABLE CLOTTING CONDITION. 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. AFTER IMPLANTING THE DEVICE, IT WAS NOTED TO BE 0.5MM AWAY FROM THE INTENDED TERMINATION SITE, THE INFERIOR VENA CAVA. ONE WEEK LATER, ON (B)(6) 2013 A REVISION PROCEDURE WAS DONE FOR A THROMBOSIS. NO STENOSIS WAS SEEN IN THE HEPATIC VEIN AT THE TIME OF THE REVISION. THE STENT WAS THEN DILATED TO 10MM REDUCING THE PORTO-SYSTEMIC VENOUS PRESSURE GRADIENT FROM 4 TO 1MM HG. IT HAS NOT BEEN CONFIRMED WHETHER THIS PT DEVELOPED HEPATIC ENCEPHALOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315303 GORE VIATORR TIPS ENDOPROSTHESIS MIR W. L. GORE ASSOCIATES

    Patients

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