BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1211488 · Received October 22, 2008

    Report

    Report Number
    2939204-2008-00484
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    June 16, 2008
    Report Date
    October 9, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON-CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THREE MONTHS PRIOR TO THE EVENT, THREE STENTS WERE SUCCESSFULLY PLACED TO TREAT THE COMPLETE OCCLUSION DUE TO A LEFT VERTEBRAL TO MID BASILAR STENOSIS. RESIDUAL STENOSIS POST PROCEDURE WAS 40%. AT ROUTINE FOLLOW UP, THE PATIENT PRESENTED WITH DIPLOPIA, INCREASING VERTIGO, VERY LOW ENERGY AND "CLOUDY MENTATION". IN STENT RESTENOSIS WAS FOUND DUE TO INTIMAL HYPERPLASIA. ANGIOPLASTY WAS PERFORMED USING A PTA DILATION CATHETER AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYSTEM (NJE) NEUROVASCULAR STENT NJE NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. WS030020 11065796

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention TWO WINGSPAN STENT (BOSTON SCIENTIFIC)| PTA DILATION CATHETER (MANUFACTURER UNKNOWN) AND