BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXT DETACHABLE COIL, HELIX SOFT

    MDR report key: 951103 · Received November 21, 2007

    Report

    Report Number
    2029214-2007-00123
    Event Type
    Injury
    Date Received
    November 21, 2007
    Date of Event
    October 5, 2007
    Report Date
    October 22, 2007
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. MODEL AND LOT NUMBERS OF OTHER COILS INVOLVED: MODEL#: N-3-6-T10-SO. LOT #: 3171705. DATE MANUFACTURE: 06/2007. EXPIRATION DATE: 06/2010. MODEL#: N-3-3-T10-TS. LOT#: #2715695. DATE MANUFACTURE: 05/2007. EXPIRATION DATE: 05/2010. MODEL#: N-2-2-T10-TS. LOT#: 3163079. DATE MANUFACTURE: 06/2007. EXPIRATION DATE: 06/2010.

    Description of Event or Problem · 1

    FOUR COILS WERE USED IN A A-COM ANEURYSM COILING PROCEDURE. POST PROCEDURE, IT WAS REPORTED THE PHYSICIAN OBSERVED METALLIC ARTIFACTS IN THE VASCULATURE DISTAL TO THE COILED ANEURYSM (FROM MRI IMAGES AND CT SCAN). NO PATIENT INJURY OR DEFICIT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT DETACHABLE COIL, HELIX SOFT ELECTROLYTICALLY DETACHABLE COIL HCG EV3 NEUROVASCULAR N-4-6-T10-SO 2189885

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability