BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM DETACHABLE COIL

    MDR report key: 1395984 · Received May 28, 2009

    Report

    Report Number
    2029214-2009-00163
    Event Type
    Injury
    Date Received
    May 28, 2009
    Date of Event
    March 10, 2009
    Report Date
    May 7, 2009
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION, AS THEY WERE IMPLANTED IN THE PT. MODELS AND LOT NUMBERS OF COILS INVOLVED: QC-3-8-3D; LOT: 6835360- DOM-10/30/2008-EXP- 1/1/2011, QC-3-8-3D; LOT: 6535123- DOM- 8/28/2011-EXP-8/1/2011, QC-2-6-HELIX; LOT: 6895723-DOM-11/25/2008- EXP-11/1/2011, QC-1.5-2-HELIX; LOT: 6576512 (QTY.2)- DOM- 9-16-2008- EXP- 9-1-2011.

    Description of Event or Problem · 1

    SIX AXIUM COILS WERE USED IN A COILING TREATMENT PROCEDURE. IT WAS REPORTED THAT UPON REMOVAL OF THE BALLOON, THE COILS WERE OBSERVED PROTRUDING INTO THE PARENT ARTERY. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-4-8-3D 3346450

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability