BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PLATINUM HELICAL DETACHABLE COIL

    MDR report key: 3901865 · Received June 30, 2014

    Report

    Report Number
    2029214-2014-00358
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 8, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION WITH IMPLANT COIL NOT ATTACHED. THE CAUSE FOR THE DETACHMENT COULD NOT BE DETERMINED; HOWEVER IT IS POSSIBLE THAT THE IMPLANT COIL DETACHED SUBSEQUENT TO THE REPORTED RESISTANCE, OR MANEUVERING OF THE DEVICE THROUGH THE REPORTED TORTUOUS ANATOMY. THE SEPARATION LIKELY OCCURRED DUE TO A BREAK IN THE DETACHMENT STICK DISTAL TO THE DETACHMENT BALL. ALL COILS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. THE AXIUM INSTRUCTIONS FOR USE STATES, ¿IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION, OR REPOSITIONING IS DIFFICULT, THE COIL HAS BEEN STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD BOTH THE CATHETER AND COIL. * ALSO, DUE TO THE DELICATE NATURE OF THE AXIUM DETACHABLE COIL, THE TORTUOUS VASCULAR PATHWAYS THAT LEAD TO CERTAIN ANEURYSMS AND VESSELS, AND THE VARYING MORPHOLOGIES OF INTRACRANIAL ANEURYSMS, A COIL MAY OCCASIONALLY STRETCH WHILE BEING MANEUVERED. STRETCHING IS A PRECURSOR TO POTENTIAL MALFUNCTIONS SUCH AS COIL BREAKAGE AND MIGRATION.¿ (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A POSTERIOR COMMUNICATING ARTERY ANEURYSM. ON (B)(6) 2014, THE PATIENT UNDERWENT COILING EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED AS THE THIRD COIL WAS ADVANCED TO THE ANEURYSM AND IT PREMATURELY DETACHED. THE DETACHED IMPLANT COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381212 AXIUM PLATINUM HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-2-HELIX 9754871

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR