BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1181613 · Received September 29, 2008

    Report

    Report Number
    2939204-2008-00390
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    February 16, 2007
    Report Date
    September 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. EVALUATION CONCLUSIONS: OTHER FOR ANTICIPATED PROCEDURAL COMPLICATION. BOSTON SCIENTIFIC HAS MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE ALLEGED EVENT WITHOUT RESULT. CURRENTLY THERE ARE NO FURTHER DETAILS TO REPORT. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED, IT WAS DETERMINED THAT THE DEVICE WAS USED IN ACCORDANCE WITH THE LABELING AND THAT THIS DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. A REVIEW OF THE LABELING FOUND THAT IT CONTAINED LANGUAGE REGARDING RESTENOSIS THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WAS ASSIGNED.

    Description of Event or Problem · 1

    THE PATIENT WAS SUCCESSFULLY TREATED FOR A STENOSIS OF THE RIGHT MIDDLE CEREBRAL ARTERY USING ANGIOPLASTY AND STENT PLACEMENT. NINE MONTHS POST PROCEDURE, THE PATIENT WAS RE-ADMITTED TO TREAT IN-STENT RESTENOSIS USING ANGIOPLASTY. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BOSTON SCIENTIFIC GATEWAY PTA BALLOON CATHETERS