BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM PGLA DETACHABLE COIL

    MDR report key: 2190930 · Received August 4, 2011

    Report

    Report Number
    2029214-2011-00199
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 6, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    COILING TREATMENT OF AN ANEURYSM. IT WAS REPORTED AFTER PLACEMENT OF TWO COILS, BLOOD CLOT WAS OBSERVED IN THE INFERIOR BRANCH OF THE MIDDLE CEREBRAL ARTERY. AN ATTEMPT TO PLACE A BALLOON IN THE BRANCH BUT WITHOUT SUCCESS. HOWEVER, THE GUIDEWIRE OF THE BALLOON ALLOWS TO PUSH THE COILS IN THE ANEURYSM. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM PGLA DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S