BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS AND NXT DETACHABLE COIL

    MDR report key: 1426975 · Received April 21, 2009

    Report

    Report Number
    2029214-2009-00103
    Event Type
    Malfunction
    Date Received
    April 21, 2009
    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: MODEL # X-5-15-T10-MC, LOT# 5347161 - DOM - 03/15/2008 - EXP - 02/01/2013. MODEL # X-5-10-T10-MC, LOT# 5374587 - DOM - 03/18/2008 - EXP - 03/01/2013. MODEL # X-3-5-T10-MC, LOT# 5052211 - DOM - 02/04/2008 - EXP - 11/01/2011. MODEL # X-3-8-T10-MC, LOT# 1873145 - DOM - 07/05/2006 - EXP - 07/01/2009. MODEL # N-2-2-T10-SO, LOT# 574940 - DOM - 05/06/2008 - EXP - 05/01/2011. MODEL # N-2-3-T10-TS, LOT# 619509 (2) - INCOMPLETE LOT NUMBERS. MODEL # X-2-2-T10-HSS, LOT# 6841985 (2) - DOM - 11/03/2008 -EXP - 11/01/2013. MODEL # X-3-4-T10-TC, LOT# 18211485 - DOM - 06/01/2006 - EXP - 06/01/2009.

    Description of Event or Problem · 1

    ELEVEN 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-6-20-T10-MC 3013077

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK