BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3140690 · Received May 31, 2013

    Report

    Report Number
    2029214-2013-00518
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE, PUSHWIRE, AND MARKSMAN CATHETER WERE RETURNED FOR EVALUATION. THE PIPELINE WAS FOUND OPENED AND RELEASED FROM THE CAPTURE COIL; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED.(B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT THE PIPELINE WAS STUCK IN THE CAPTURE COIL. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242110 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77375-12 9648798

    Patients

    Seq Age Sex Outcome Treatment
    1