BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 2973083 · Received February 21, 2013

    Report

    Report Number
    2029214-2013-00155
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED; HOWEVER, THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A DISSECTING CEREBRAL ANEURYSM AT THE VERTEBRAL ARTERY. DURING THE PROCEDURE, IT WAS REPORTED THAT THE SECOND IMPLANT COIL WOULD NOT DETACH WITH THE INSTANT DETACHER OR VIA BREAKING OF THE HYPO-TUBE (AN ALTERNATE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE). THE COIL WAS REMOVED FROM THE PATIENT ALONG WITH THE PUSHWIRE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75583 AXIUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-5-15-3D 9670725

    Patients

    Seq Age Sex Outcome Treatment
    1