BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL HLX

    MDR report key: 9976014 · Received April 20, 2020

    Report

    Report Number
    2029214-2020-00371
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    March 26, 2020
    Report Date
    April 19, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRD
    UDI-DI
    00847536020955
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT THE AXIUM COIL FAILED TO DETACH VIA THE MANUAL METHOD. APB-1.5-3-HX-ES COULD NOT BE DETACHED, AFTER IT COMPLETELY ENTERED THE ANEURYSM. AN INSTANT DETACHER WAS NOT USED. 5 MANUAL DETACHMENT ATTEMPTS WERE MADE BUT ALL WERE UNSUCCESSFUL. IMAGES HAVE BEEN PROVIDED. THE PATIENT WAS TREATED WITH QC-1.5-2-HELIX AND APB-1.5-1-HX-ES AND THEY WERE USED SUCCESSFULLY. THE PATIENT WAS BEING TREATED FOR A RUPTURED, SACCULAR, CAVERNOUS SINUS ARTERY. THE MAX DIAMETER WAS 2.5 MM AND THE NECK WAS 2 MM. THE BLOOD FLOW AND VESSEL ANATOMY WERE BOOTH NORMAL. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442914 AXIUM PRIME BRPL HLX DEVICE, EMBOLIZATION, VASCULAR KRD MICRO THERAPEUTICS, INC. DBA EV3 APB-1.5-3-HX-ES A962595 00847536020955

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR