BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 STENT DELIVERY SYSTEM

    MDR report key: 1211745 · Received October 24, 2008

    Report

    Report Number
    2939204-2008-00501
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    January 15, 2008
    Report Date
    October 6, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT CODE: OTHER FOR TRANSIENT HAND DISCOORDINATION. DEVICE CODE: OTHER FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PT UNDERWENT THE SUCCESSFUL STENT ASSISTED EMBOLIZATION OF RIGHT PARACLINOID/OPHTHALMIC ARTERY ANEURYSM. ONE MONTH POST PROCEDURE, THE PT PRESENTED WITH TRANSIENT HAND DISCOORDINATION "POSSIBLY DUE TO A SMALL EMBOLIC EVENT." THE PT WAS TREATED WITH ASPIRIN THERAPY THAT THE PT HAD PREVIOUSLY STOPPED. TWO MONTHS LATER, IT WAS REPORTED THAT THE DISCOORDINATION WAS RESOLVED WITHOUT ANY RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 STENT DELIVERY SYSTEM (NJE) NEUROVASCULAR STENT NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. SNF34020 9569761

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SIX BOSTON SCIENTIFIC GDC COILS