BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM HELICAL DETACHABLE COIL

    MDR report key: 3182091 · Received June 21, 2013

    Report

    Report Number
    2029214-2013-00581
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 26, 2013
    Report Date
    May 26, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).

    Additional Manufacturer Narrative · 1

    THE PUSHER ASSEMBLY WAS RETURNED FOR EVALUATION WITHOUT THE DETACHED IMPLANT COIL AS IT WAS LOST (OUTSIDE THE PATIENT) AT THE SITE. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE PUSHER ASSEMBLY WAS FOUND BROKEN WHICH LIKELY LED TO THE DETACHMENT OF THE IMPLANT COIL. (B)(4)

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE COILING PROCEDURE, IT WAS REPORTED THAT THE FIRST TWO COILS WERE IMPLANTED INTO THE ANEURYSM WITHOUT ANY ISSUES; HOWEVER, THE THIRD PIPELINE COULD NOT BE DETACHED WITH THE INSTANT DETACHER OR VIA THE MANUAL METHOD (AN ALTERNATIVE DETACHMENT METHOD PRESENTED IN THE INSTRUCTIONS FOR USE). UPON WITHDRAWING THE COIL BACK, IT WAS DISCOVERED THAT THE IMPLANT COIL HAD DETACHED AND WAS LOST.NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283499 AXIUM HELICAL DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-2-3-HELIX 9712447

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR