BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PLATINUM 3D DETACHABLE COIL

    MDR report key: 3875353 · Received June 16, 2014

    Report

    Report Number
    2029214-2014-00342
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 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.

    Additional Manufacturer Narrative · 1

    THE PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION WITH THE IMPLANT COIL STILL ATTACHED WHICH CONTRADICTS WHAT WAS REPORTED IN THE EVENT DESCRIPTION. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE REPORTED EVENT. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. ON (B)(6) 2014, THE PATIENT UNDERWENT COILING EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE COIL COULD NOT BE PULLED INTO THE MICROCATHETER IN ORDER TO REPOSITION IT INSIDE THE ANEURYSM. THE IMPLANT COIL WAS FOUND TO BE PREMATURELY DETACHED AS IT WAS WITHDRAWN OUT OF THE PATIENT WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW PRODUCT.NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352994 AXIUM PLATINUM 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-4-3D 9740365

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR