BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV3

    MDR report key: 4059239 · Received August 27, 2014

    Report

    Report Number
    MW5038018
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 12, 2014
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A STENT THAT WAS GOING TO BE PLACED IN PT'S RIGHT TIBIAL PERONEAL TRUNK WOULD NOT PASS OVER THE AMPLATZ WIRE. CORRECT SHEATH SIZE WAS IN, CORRECT WIRE SIZE WAS IN. THE STENT WAS STUCK, UNABLE TO DEPLOY STENT TO APPROPRIATE SITE. UNABLE TO FIX THE PT'S VASCULAR PROBLEM. WIRE AND STENT REMOVED WITHOUT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522739 EV3 PROTEGE EVERFLEX SELF-EXPANDING FGE EV3 INC. PRB35-05-020-120 9910059

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR