BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIUM 3D DETACHABLE COIL

    MDR report key: 1002541 · Received February 26, 2008

    Report

    Report Number
    2029214-2008-00020
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 29, 2008
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RETURNED AND THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    DURING COILING TREATMENT PROCEDURE, IT WAS REPORTED THE COIL DETACHED WITHOUT MANIPULATION AND WAS SUCCESSFULLY RETRIEVED WITH A SNARE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM 3D DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR QC-8-203D 4472491

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention