BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT XL

    MDR report key: 3896605 · Received June 17, 2014

    Report

    Report Number
    3896605
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 17, 2014
    Manufacturer
    C.R. BARD, INC.
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STENT PARTIALLY DEPLOYED PRIOR TO BEING PLACED IN THE PATIENT. STENT DEPLOYED EVEN THOUGH THE SAFETY TO PREVENT DEPLOYMENT REMAINED INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355923 LIFESTENT XL STENT, SUPERFICIAL FEMORAL ARTERY NIP C.R. BARD, INC. * ANXH0595

    Patients

    Seq Age Sex Outcome Treatment
    1 *