BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM PLATINUM 3-D DETACHABLE COIL

    MDR report key: 3792725 · Received May 6, 2014

    Report

    Report Number
    2029214-2014-00258
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 11, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUSHER ASSEMBLY WAS RETURNED WITHOUT THE IMPLANT COIL AS IT REMAINED IN THE PATIENT. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT. THERE IS A WARNING IN THE AXIUM IFU (INSTRUCTIONS FOR USE) THAT STATES, "IF AXIUM DETACHABLE COIL REPOSITIONING IS NECESSARY, TAKE SPECIAL CARE TO RETRACT COIL UNDER FLUOROSCOPY IN A ONE-TO-ONE MOTION WITH THE IMPLANTED PUSHER. IF THE COIL DOES NOT MOVE WITH A ONE-TO-ONE MOTION, OR REPOSITIONING IS DIFFICULT, THE COIL HAS BEEN STRETCHED AND COULD POSSIBLY BREAK. GENTLY REMOVE AND DISCARD BOTH THE CATHETER AND THE COIL." (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A SMALL BERRY ANEURYSM MEASURING 3.0MM X 5.0MM LOCATED IN THE CENTER OF THE A-COMM (ANTERIOR COMMUNICATING) ARTERY. THE PATIENT UNDERWENT EMBOLIZATION TREATMENT ON (B)(6) 2014. DURING THE PROCEDURE, IT WAS REPORTED THE IMPLANT COIL PREMATURELY DETACHED AS THE PUSHER WAS PULLED BACK IN ORDER TO REPOSITION THE COIL INSIDE THE ANEURYSM. THE DETACHED IMPLANT COIL WILL NOT BE REMOVED FROM THE PATIENT SINCE THE PHYSICIANS WERE SATISFIED WITH THE LOCATION OF THE IMPLANT COIL. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270573 AXIUM PLATINUM 3-D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-6-3D 9845199

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability