BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PLATINUM 3-D DETACHABLE COIL

    MDR report key: 3800984 · Received May 8, 2014

    Report

    Report Number
    2029214-2014-00248
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 5, 2014
    Report Date
    April 9, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHER ASSEMBLY, DETACHED IMPLANT COIL, AND MICROCATHETER WERE RETURNED FOR EVALUATION. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM LOCATED IN THE A-COMM (ANTERIOR COMMUNICATING) ARTERY. ON (B)(6) 2014, THE PATIENT UNDERWENT EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE IMPLANT COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE DETACHED COIL AND MICROCATHETER WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NEW DEVICES. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277320 AXIUM PLATINUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-4-3D 9724388

    Patients

    Seq Age Sex Outcome Treatment
    1