BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISO-PRO

    MDR report key: 2954024 · Received January 25, 2013

    Report

    Report Number
    2954024
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE STENT DEPLOYED PREMATURELY FROM THE SHEATH. THE PHYSICIAN USED A SNARE TO RETRIEVE THE STENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BOOKED AS: AGRAM, ANGIO, SMA CELIAC, PTA AND STENT MESSINTARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35458 VISO-PRO STENT, BILIARY FGE EV3 NEUROVASCULAR PXB35-06-17-080 9595926

    Patients

    Seq Age Sex Outcome Treatment
    1 *