BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM

    MDR report key: 2479637 · Received February 29, 2012

    Report

    Report Number
    MW5024499
    Event Type
    Malfunction
    Date Received
    February 29, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 29, 2012
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS BILIARY STENT SELF DEPLOYED BEFORE REACHING PT. A NEW STENT WAS USED AND OPERATED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM BILIARY STENT SYSTEM FGE EV3 INC. PRB35-08-040-080 9439747

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR