BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3933993 · Received June 10, 2014

    Report

    Report Number
    3933993
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 10, 2014
    Manufacturer
    EV3 INC.
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PIPELINE EMBOLIZATION DEVICE FAILED TO DEPLOY AS INTENDED PRIOR TO BEING PLACED NEAR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336870 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT EV3 INC. * 9874057

    Patients

    Seq Age Sex Outcome Treatment
    1 *