BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PGLA 3D DETACHABLE COIL

    MDR report key: 3231798 · Received December 6, 2012

    Report

    Report Number
    2029214-2012-00683
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 6, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EVALUATED AND IT WAS CONFIRMED THE IMPLANT COIL WAS STILL ATTACHED TO THE PUSHWIRE, BUT THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE IMPLANT COIL DID NOT DETACH AFTER SEVERAL ATTEMPTS. NO INJURY WAS REPORTED WITH THE PT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR # 2029214-2012-00684.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM PGLA 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR PC-2-6-3D 9468966

    Patients

    Seq Age Sex Outcome Treatment
    1