BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINGSPAN STENT SYSTEM

    MDR report key: 1211589 · Received October 23, 2008

    Report

    Report Number
    2939204-2008-00500
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 10, 2008
    Manufacturer
    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

    NO ALLEGATIONS OF ANY DEVICE MALFUNCTION OR NONCONFORMANCE THAT CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    FOUR MONTHS PRIOR TO THE PATIENT PRESENTING WITH DIZZINESS AND POSSIBLE HYPOPERFUSION OF THE POSTERIOR CIRCULATION, THE STENT (SUBJECT DEVICE) WAS SUCCESSFULLY PLACED. AN ANGIOGRAM WAS PERFORMED AND FOUND THAT THE PREVIOUSLY IMPLANTED STENT SHOWED TO BE 80% RE-STENOSED. ANGIOPLASTY WAS PERFORMED AND FOUND THAT THE VESSEL DIAMETER IMPROVED TO 63%. IT WAS REPORTED THAT THE SYMPTOMS RESOLVED WHEN ASSESSED THE FOLLOWING MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT SYSTEM (NJE) INTRACRANIAL STENT NJE BOSTON SCIENTIFIC CORP. WS040015 11421829

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention