BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 MICRODELIVERY STENT SYSTEM

    MDR report key: 908728 · Received September 7, 2007

    Report

    Report Number
    6000078-2007-00222
    Event Type
    Injury
    Date Received
    September 7, 2007
    Date of Event
    August 15, 2007
    Report Date
    August 15, 2007
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): H020002/S5. THE DEVICE IN QUESTION WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS AS IT REMAINS IMPLANTED IN THE PT. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. THE ROOT CAUSE OF THIS EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS STENT WAS PREMATURELY DEPLOYED DURING THE PROCEDURE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE STENT WITH A SNARE. HE THEN DECIDED TO ABORT THE PROCEDURE ONCE THE STENT WAS IN THE LEFT FEMORAL ARTERY, WHERE IT REMAINS. THE PT WAS REPORTED TO BE IN STABLE CONDITION. ALTHOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM 3 MICRODELIVERY STENT SYSTEM (NJE) INTRAVASCULAR STENT NJE BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION SNF33020 9086506

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention