BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS AND NXT DETACHABLE COIL

    MDR report key: 1426978 · Received April 21, 2009

    Report

    Report Number
    2029214-2009-00132
    Event Type
    Malfunction
    Date Received
    April 21, 2009
    Date of Event
    December 30, 2008
    Report Date
    March 23, 2009
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR INVESTIGATION AS IT WAS CONSUMED IN THE EVENT. REVIEW FOR MR ARTIFACT: TWO PHYSICIANS HAVE RETROSPECTIVELY REVIEWED ANEURYSM COILING CASE REPORTS FROM 2007 TO 2008 THAT HAD MR FOLLOW UP. ADDITIONAL CERS ARE BEING WRITTEN FOR ALL CASES BROUGHT TO EV3'S ATTENTION THAT HAVE MR ARTIFACT. ALL ADVERSE EVENTS AND DEVICE MALFUNCTIONS REPORTED DURING THIS RETROSPECTIVE REVIEW WERE ENTERED IN THE COMPLAINT SYSTEM AND ASSESSED FOR MDR REPORTABILITY PER EV3 PROCEDURES. AS A RESULT, 38 EVENTS WERE IDENTIFIED THAT MET THE MDR REPORTING REQUIREMENT AND ARE BEING SUBMITTED TO THE FDA. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THESE EVENTS. MDR NUMBERS: 2029214-2009-00095 TO 2029214-2009-00132. MODELS AND LOT NUMBERS OF COILS INVOLVED: N-3-10-T10-F, LOT 6799028 (QTY. 4) - DOM - 10/21/2008 - EXP - 10/01/2011. N-2-6-T10-F, LOT 3161896 - DOM 06/27/2007 - EXP - 06/01/2010. X-2-2-T10-HSS, LOT 6841985 - DOM 11/03/2008 - EXP 11/01/2013. N-2-6-T10-F, LOT 6838771 (QTY. 6) - DOM - 10/31/2008 - EXP - 10/01/2011. X-2-2-T10-HSS, LOT 5330703 (QTY. 5) - DOM - 03/12/2008 - EXP - 03/01/2013. X-2-2-T10-HSS, LOT 5638361 (QTY. 2) - DOM - 02/22/2008 -EXP - 02/01/2013. X-2-2-T10-HSS, LOT 5330704 (QTY. 4) - DOM - 03/12/2008 - EXP - 03/01/2013. X-2-4-T10-HSS, LOT 5300020 (QTY. 2) - DOM - 03/07/2008 - EXP - 03/01/2013. X-2-4-T10-HSS, LOT 5298799 (QTY. 3) - DOM -03/07/2008 - EXP 03/01/2013.

    Description of Event or Problem · 1

    SEVERAL NEXUS AND NXT 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 PATIENT 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-8-15-T10-MC 081000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK