BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 6099823 · Received November 14, 2016

    Report

    Report Number
    6099823
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    August 29, 2016
    Report Date
    October 12, 2016
    Manufacturer
    MEDTRONIC/COVIDIEN FORMERLY MICRO THERAPEUTICS, INC. DBA EV
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE STENT BECAME DETACHED IN THE DELIVERY CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751467 PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MEDTRONIC/COVIDIEN FORMERLY MICRO THERAPEUTICS, INC. DBA EV PED 350 18 A249773

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN.