BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM 3D DETACHABLE COIL

    MDR report key: 3073454 · Received April 23, 2013

    Report

    Report Number
    2029214-2013-00392
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELIVERY PUSHER WAS RETURNED FOR EVALUATION AND IT WAS FOUND BROKEN WITH THE RELEASE WIRE PULLED BACK WHICH LIKELY CAUSED THE IMPLANT COIL TO DETACH.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A RUPTURED OPHTHALMIC ICA (INTERNAL CAROTID ARTERY) CEREBRAL ANEURYSM MEASURING 10MM X 8.2MM X 10.2MM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT COIL COULD NOT BE DETACHED WITH THE INSTANT DETACHER. UPON RETRIEVAL OF THE IMPLANT COIL, IT PREMATURELY DETACHED WITH APPROXIMATELY 15MM OF IT INSIDE THE CATHETER. A TRAXCESS GUIDEWIRE WAS USED TO PUSH THE COIL INTO THE ANEURYSM AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173788 AXIUM 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-9-20-3D 9669858

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability