BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV3 INC, PROTEGE EVER FLEX STENT SYSTEM

    MDR report key: 8428555 · Received March 15, 2019

    Report

    Report Number
    MW5084980
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    September 5, 2018
    Report Date
    March 14, 2019
    Manufacturer
    EV3 INC./MEDTRONIC INC.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STENT DEPLOYED IN LEFT FEMORAL ARTERY IN NORMAL FASHION. NO PROBLEM/ISSUE WITH ACTUAL DEPLOYMENT AND PLACEMENT OF STENT. HOWEVER, UPON REMOVAL OF DEVICE FROM PT, THE INNER PART OF THE DEVICE PULLED APART FROM THE EXTERNAL PART. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218873 EV3 INC, PROTEGE EVER FLEX STENT SYSTEM STENTS, DRAINS AND DILATORS FOR THE BILLARY DUCTS FGE EV3 INC./MEDTRONIC INC. A605038

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR