BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM HELICAL DETACHABLE COIL

    MDR report key: 2902205 · Received January 8, 2013

    Report

    Report Number
    2029214-2013-00014
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 11, 2012
    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 PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION AND THE TACK WELD WAS FOUND TO BE BROKEN. THE BROKEN TACK WELD LIKELY CAUSED THE COIL TO DETACH.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN INTERNAL CAROTID ARTERY (ICA) - SUPERIOR HYPOPHYSEAL ARTERY (SHA) ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE COIL PREMATURELY DETACHED WHEN THE PHYSICIAN TRIED TO REPOSITION THE COIL. THE PHYSICIAN WAS ABLE TO PUSH THE IMPLANT COIL SUCCESSFULLY INTO THE ANEURYSM WITH THE DELIVERY PUSHER. NO INJURIES WERE REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9566 AXIUM HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-3-HELIX 9401233

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability