BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS AND NXT DETACHABLE COIL

    MDR report key: 2548147 · Received January 16, 2009

    Report

    Report Number
    2029214-2008-00331
    Event Type
    Injury
    Date Received
    January 16, 2009
    Report Date
    December 17, 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 WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. MODELS AND LOT NUMBER INVOLVED: (ADDITIONAL) - MODEL NUMBER: X-5-15-T10-MC / LOT NUMBER: 5347161 - DOM: 03/15/2008 - EXP: 02/01/2013. MODEL NUMBER: X-5-10-T10-MC / LOT NUMBER: 5374587 - DOM: 03/18/2008 - EXP: 03/01/2013. MODEL NUMBER: X-3-5-T10-MC / LOT NUMBER: 5052211 - DOM: 02/04/2008 - EXP: 11/01/2011. MODEL NUMBER: X-3-8-T10-MC / LOT NUMBER 1873145 - DOM: 07/05/2006 - EXP: 07/01/2009. MODEL NUMBER: N-2-T10-SO / LOT NUMBER: 5749401 - DOM: 05/06/2008 - EXP: 05/01/2011. MODEL NUMBER: N-2-3-T10-TS / LOT NUMBER: 6196509 - DOM: 07/07/2008 - EXP: 07/01/2011. MODEL NUMBER: X-2-2-T10-HSS / LOT NUMBER: 6841985 - DOM: 11/03/2008 - EXP: 11/01/2013. MODEL NUMBER: X-3-4-T10-TC / LOT NUMBER: 1821145 - DOM: 06/01/2006 - EXP: 06/01/2009.

    Description of Event or Problem · 1

    NINE COILS WERE USED IN AN ANEURYSM COILING PROCEDURE. POST PROCEDURE, IT WAS REPORTED THE PATIENT DEVELOPED TRANSIENT ISCHEMIC ATTACK (TIA) AND HEMIPARESIS. THE REPORT ALSO MENTIONED THAT THE PHYSICIAN OBSERVED A METALLIC ARTIFACT SOME DISTANCE AWAY FROM THE ANEURYSM (FROM MRI IMAGES). THE PATIENT STATUS WAS REPORTED AS 'DOING BETTER'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS AND NXT DETACHABLE COIL DETACHABLE COIL HCG EV3 NEUROVASCULAR X-6-20-T10-MC 3013077

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability