BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM 3-D DETACHABLE COIL

    MDR report key: 1984136 · Received February 10, 2011

    Report

    Report Number
    2029214-2011-00034
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 13, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE COIL IMPLANT HAS BEEN SEPARATED FROM THE DELIVERY SYSTEM AND STAYED INSIDE THE CATHETER. NO PATIENT INJURY REPORTED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. IT WAS REPORTED AFTER THE COIL WAS IMPLANTED, THE COIL CAME BACK INSIDE THE CATHETER WHILE WITHDRAWING THE PUSHWIRE. THE ENTIRE SYSTEM (CATHETER AND COIL) WAS REMOVED FROM THE PATIENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-4-12-3D 9290162

    Patients

    Seq Age Sex Outcome Treatment
    1