BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 774865 · Received October 25, 2006

    Report

    Report Number
    6000078-2006-00523
    Event Type
    Injury
    Date Received
    October 25, 2006
    Date of Event
    September 27, 2006
    Report Date
    October 3, 2006
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    NJE
    PMA / PMN Number
    h020002/s4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WILL NOT BE RETURNED TO THE MFR BECAUSE IT REMAINS IMPLANTED. BASED ON THE INFO KNOWN AT THIS TIME, THE MFR CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE PT INJURY EXPERIENCED BY THE USER. NO CONCLUSION CAN BE DRAWN. IF FURTHER SIGNIFICANT INFO IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW. G5: PMA/510(K)#: H020002/S5.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED A SUCCESSFUL INTRACRANIAL STENTING PROCEDURE OF THE BRAIN WHERE AN ADVERSE EVENT OCCURRED TWO DAYS FOLLOWING. THE USER SUCCESSFULLY DEPLOYED TOW STENTS (ONE STENT IS THE DEVICE IN QUESTION) OVER THE ANEURYSM. TWO DAYS LATER, THE PT HAD A CEREBELLAR INFARCT. THE HOSPITAL REPORTED THAT THERE WERE NO COMPLICATIONS AT THE CLOSE OF THE PROCEDURE. THE USER AND THE USER'S ASSISTANT INFORMED THE SALES REPRESENTATIVE THAT THEY FELT THE ADVERSE EVENT IS UNRELATED TO THE USE OF THE DEVICE IN QUESTION, THOUGH THEY ARE NOT CERTAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE- STENT, INTRACRANIAL NEUROVASCULAR NJE NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION SNF34515 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L NEUROFORM STENT, THERAPY DATE: