BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM PLATINUM HELICAL DETACHABLE COIL

    MDR report key: 3328361 · Received September 5, 2013

    Report

    Report Number
    2029214-2013-00747
    Event Type
    Injury
    Date Received
    September 5, 2013
    Date of Event
    August 2, 2013
    Report Date
    August 8, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT COIL PREMATURELY DETACHED AND AN SAB (SOLITAIRE AB) STENT WAS USED TO PIN THE DETACHED IMPLANT COIL AGAINST THE CAROTID ARTERY.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441513 AXIUM PLATINUM HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-6-HELIX 9702582

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S