BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE VIATORR TIPS ENDOPROSTHESIS

    MDR report key: 3012702 · Received February 22, 2013

    Report

    Report Number
    3007284313-2013-00005
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 25, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS. AN ENGINEERING ANALYSIS IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED A PHYSICIAN WAS IMPLANTING A VIATORR TRANSJUGULAR INTRAHEPATIC PORTO-SYSTEMIC SHUNT (TIPS) ENDOPROSTHESIS IN A PT WAS GASTRIC VARICEAL BLEEDING. THE PORTAL VEIN WAS ACCESSED AND THE TRACK THROUGH THE LIVER WAS DILATED TO 8 MM. THE VIATORR DEVICE WAS ADVANCED THROUGH A 10FR INTRODUCER SHEATH. THE UNCOVERED PORTION WAS DEPLOYED IN THE PORTAL VEIN BY WITHDRAWING THE SHEATH. PLACEMENT OF THE DEVICE IN THE PORTAL VEIN WAS CONFIRMED FLUOROSCOPICALLY BY THE RADIOPAQUE MARKER BAND. ONCE THE STENT WAS IN POSITION, THE SHEATH WAS WITHDRAWN TO THE RIGHT ATRIUM. IN AN ATTEMPT TO DEPLOY THE REMAINDER OF THE STENT, RESISTANCE WAS FELT. INSTEAD OF UNRAVELING, THE DEPLOYMENT LINE TIGHTENED AROUND THE STENT AND PULLED IT OUT OF THE TRANSHEPATIC TRACK, LEAVING IT HALF IN THE RIGHT HEPATIC VEIN AND HALF IN THE RIGHT ATRIUM. THE STENT AND DELIVERY SYSTEM WERE RETRIEVED VIA WIRE SNARE THROUGH A 16FR SHEATH. THE TRANSHEPATIC TRACK WAS RECANNULATED AND SECOND VIATORR DEVICE WAS DEPLOYED WITHOUT INCIDENT. THE STENT APPEARED A LITTLE SHORT, SO A PROTÉGÉ STENT WAS ADDED TO GAIN LENGTH TO THE RIGHT ATRIUM. THE TRACK WAS REANGIOPLASTIED TO 10 MM. THE PT DID WELL FOLLOWING THE PROCEDURE ALTHOUGH DURING THE FIRST STENT PLACEMENT AND REMOVAL, THE PT EXPERIENCED MULTIPLE ATRIAL ECTOPIC BEATS WHICH RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78793 GORE VIATORR TIPS ENDOPROSTHESIS MIR / SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W. L. GORE & ASSOCIATES 10741794

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 16 FR INTRODUCER SHEATH| GUIDEWIRE| 10 FR INTRODUCER SHEATH