BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM DETACHABLE COIL SYSTEM

    MDR report key: 1288541 · Received January 14, 2009

    Report

    Report Number
    2029214-2009-00010
    Event Type
    Injury
    Date Received
    January 14, 2009
    Date of Event
    November 14, 2008
    Report Date
    December 9, 2008
    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 DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR INVESTIGATION, AS IT WAS CONSUMED IN THE EVENT. REGISTRY PERTAINING TO THE EVALUATION OF AXIUM DETACHABLE COILS IN THE TREATMENT OF INTRACRANIAL ANEURYSMS. PROSPECTIVE, MULTI-CENTER IN OTHER COUNTRIES. ENROLLMENT STARTED IN 2008; ENROLLMENT ONGOING. TARGET 300 PATIENTS. MDR NUMBERS: 2029214-2008-00207 TO 2029214-2008-00237 AND 2029214-2009-00007 TO 2022914-2009-00014.

    Description of Event or Problem · 1

    INFO FROM TRIAL DATABASE. HYDROCEPHALUS. COILS USED: QC-3-6-3D, QC-3-4-HELIX, QC-2-8-HELIX, QC-2-4-HELIX.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention