BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM DETACHABLE COIL

    MDR report key: 2063438 · Received April 19, 2011

    Report

    Report Number
    2029214-2011-00077
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 24, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE COIL PERFORATED THE ANEURYSM DURING PROCEDURE. NO COMPLICATIONS WERE REPORTED WITH THE PATIENT AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-6-20-HELIX 9291698

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S