BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO PTA BLLOON CATHETER

    MDR report key: 1901414 · Received November 3, 2010

    Report

    Report Number
    2183870-2010-00170
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. HOWEVER, THIS PROCEDURE WAS AN OFF-LABEL USE OF THE VISI-PRO STENT DEVICE.

    Description of Event or Problem · 1

    THE VISI-PRO STENT WAS INTENDED TO BE IMPLANTED IN THE PROXIMAL LEFT PULMONARY ARTERY, BETWEEN 2 PREVIOUSLY IMPLANTED STENTS. DURING TRACKING OF THE STENT THE PROXIMAL AND DISTAL TINES PROTRUDED OFF THE BALLOON CATHETER UPON ATTEMPT TO INSERT THROUGH FIRST STENT. THE VISI-PRO STENT STARTED TO DISLODGE FROM DELIVERY BALLOON, THEREFORE, THE VISI-PRO STENT HAD TO BE PLACED IN THE INFRAHEPATIC INFERIOR VENA CAVA. THE DELIVERY BALLOON WAS REMOVED. DURING MIGRATION OF THE STENT, THE TRICUSPID VALVE WAS TORN. THE PT HAD A TRICUSPID VALVULOPLASTY PERFORMED THE NEXT DAY AND WAS STABLE POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISI-PRO PTA BLLOON CATHETER FGE EV3 INC. PXB35-07-17-135 6937310

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention 6F GUIDING CATHETER| PALMAZ STENTS| GENESIS| .035 ROSEN WIRE