BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 7073191 · Received November 30, 2017

    Report

    Report Number
    2029214-2017-01316
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    September 4, 2017
    Report Date
    November 30, 2017
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED FOR EVALUATION AS THEY WERE DISCARDED; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED. MDRS RELATED TO THE EVENT: 2029214-2017-01314, 2029214-2017-01315, 2029214-2017-01317. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT ONE FLOW DIVERTER DEVICE COULD NOT BE ADVANCED TO THE DESIRED POSITION AND WAS NOT ABLE TO FULLY EXPAND ONCE IT WAS RESHEATHED AND REPOSITIONED. THIS FAILURE WAS REPORTED AS NOT RELATED TO TWIST OR ANY FOCAL ANATOMIC REASON. THREE ADDITIONAL FLOW DIVERTER DEVICES WERE USED AND ALL THREE FAILED TO FULLY EXPAND AT THE DISTAL BRAID SO THEY WERE RESHEATHED AND REMOVED. THIS EVENT OCCURRED IN THE SUPRACLINOID INTERNAL CAROTID ARTERY (ICA). THERE ARE PLANS TO TREAT THE PATIENT WITH ANEURYSM OCCLUSION. THE XT-27 CATHETER WAS USED TO DELIVER ALL FOUR FLOW DIVERTER DEVICES. THERE WAS NO RESISTANCE WHEN THE DEVICES WERE ADVANCED OR RETRIEVED. THE PATIENT¿S VASCULATURE WAS MODERATE IN TORTUOSITY. ALL THE DEVICES WERE REMOVED FROM THE PATIENT AND DISCARDED AT THE SITE. THE PATIENT WAS DISCHARGED NEXT DAY. NO PATIENT INJURY OCCURRED. ANCILLARY DEVICES: 6FR SUPER ARROWFLEX, NAVIEN 058, XT 27, SYNCHRO 0.014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850688 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PED2-450-20 A358493

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR