BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM HELIX DETACHABLE COIL

    MDR report key: 1395983 · Received May 28, 2009

    Report

    Report Number
    2029214-2009-00161
    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
    WI, 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 NUMBER OF COILS INVOLVED: QC-2-8-HELIX, LOT# 6667341- DOM-10/1/2008- EXP- 10/1/2011. QC-2-2-HELIX, LOT# 7020033- DOM- 1/30/2009- EXP- 1/1/2012, QC-2-2-HELIX, LOT# 6983612- DOM- 12/29/2008- EXP- 3/1/2011.

    Description of Event or Problem · 1

    FOUR AXIUM COILS WERE USED IN A TREATMENT OF A WIDE NECK BASILAR TIP ANEURYSM. IT WAS REPORTED THAT COIL PROTRUSION OCCURRED, DUE TO THE WIDE NECK OF THE ANEURYSM AND A STENT WAS USED TO CORRECT THE COIL PROTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM HELIX DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-3-6-HELIX 6667343

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention