BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLEX

    MDR report key: 4651779 · Received February 9, 2015

    Report

    Report Number
    4651779
    Event Type
    Malfunction
    Date Received
    February 9, 2015
    Date of Event
    August 26, 2014
    Report Date
    September 24, 2014
    Manufacturer
    EV3, INC.
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    A STENT WOULD NOT PASS THROUGH A 6-FRENCH ANSEL SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91614 EVERFLEX STENT, SUPERFICIAL FEMORAL ARTERY NIP EV3, INC. PRB3506150 9861962

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR