BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS AND NXT DETACHABLE COIL

    MDR report key: 1345606 · Received March 17, 2009

    Report

    Report Number
    2029214-2009-00071
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    June 17, 2008
    Report Date
    February 17, 2009
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PT. ADDITIONAL MODELS AND LOT NUMBERS INVOLVED: MODEL # X-12-23-T10-TC, LOT # 2252193, DATE MANUFACTURE 12/7/2006, EXPIRATION DATE 12/1/2009; X-10-30-T10-MC, 5389705, 3/20/2008, 3/1/2013; X-10-20-T10-MC, 2123548, (2) EACH, 10/9/2006, 10/1/2009; X-3-4-T10-HSS, 1962290, 8/11/2006, 8/1/2009; N-10-20-T10-TC, 1920300, 7/24/2006, 7/1/2009; X-10-20-T10-TC, 1488175, 11/29/2005, 12/1/2008; N-10-20-T10-TC, 2342349, 1/11/2007, 6/1/2008; X-10-20-T10-MC, 4758773, 12/18/2007, 10/1/2009; X-6-20-T10-MC, 5425364, 3/26/2008, 3/1/2013; X-4-10-T10-HSS, 2290322, 12/21/2006, 12/1/2009; X-2-4-T10-HSS, 5241944, 3/1/2008, 3/1/2013; X-2-2-T10-HSS, 3856576, 9/15/2007, 9/1/2010; X-2-2-T10-HSS, 5267673, 3/4/2008, 1/1/2012.

    Description of Event or Problem · 1

    FIFTEEN COILS WERE USED IN AN ANEURYSM COILING PROCEDURE. POST PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN OBSERVED A METALLIC ARTIFACT NEAR THE ANEURYSM ON MRI IMAGES. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS AND NXT DETACHABLE COIL ELECTROLYTICALLY DETACHABLE COIL HCG EV3 NEUROVASCULAR X-14-26-T10-TC 2218995

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK