BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS MULTI-DIAMETER SCR AND NXT HELIX SOFT

    MDR report key: 1269826 · Received December 18, 2008

    Report

    Report Number
    2029214-2008-00314
    Event Type
    Injury
    Date Received
    December 18, 2008
    Date of Event
    November 22, 2008
    Report Date
    November 24, 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 PT. MODELS AND LOT NUMBERS INVOLVED: MODEL#: X-5-15-T10-MC, LOT#: 5358776, DATE MANUFACTURE: 3/15/2008, EXPIRATION DATE: 03/01/2013. MODEL#: X-4-5-T10-MC, LOT#: 5440486, DATE MANUFACTURE: 3/28/2008, EXPIRATION DATE: 12/01/2011. MODEL#: X-3-8-T10-MC, LOT#: 5664568, DATE MANUFACTURE: 04/25/2008, EXPIRATION DATE: 04/01/2013. MODEL#: N-2-3-T10-TS, LOT#: 5969676 (2EA) DATE MANUFACTURE: 06/09/2008, EXPIRATION DATE: 06/01/2011. MODEL#: X-2-3-T10-HSS, LOT#: 5347328, DATE MANUFACTURE: 03/15/2008, EXPIRATION DATE: 02/01/2013. MODEL#: X-2-2-T10-HSS, LOT#: 5347320, DATE MANUFACTURE: 03/15/2008, EXPIRATION DATE: 02/01/2013.

    Description of Event or Problem · 1

    EIGHT COILS WERE USED IN A RUPTURED ANEURYSM COILING PROCEDURE. POST PROCEDURE, IT WAS REPORTED THE PHYSICIAN OBSERVED A METALLIC ARTIFACT NEAR THE ANEURYSM (FROM MRI IMAGES). NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS MULTI-DIAMETER SCR AND NXT HELIX SOFT ELECTROLYTICALLY DETACHABLE COIL HCG EV3 NEUROVASCULAR X-6-20-T10-MC 5330697

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability