BEUDAMED
    FDA Adverse Event Death Summary report: N

    NJE - STENT, INTRACRANIAL NEUROVASCULAR

    MDR report key: 947152 · Received November 13, 2007

    Report

    Report Number
    6000078-2007-00299
    Event Type
    Death
    Date Received
    November 13, 2007
    Date of Event
    April 6, 2006
    Report Date
    October 15, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IMPLANTED, HOWEVER, PATIENT EXPERIENCED COMPLICATIONS AND EXPIRED. THE REPORTED ADVERSE EVENT IS DOCUMENTED IN THE DEVICE DIRECTIONS FOR USE. BASED ON THE INFORMATION KNOWN AT THIS TIME, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. NO CONCLUSION CAN BE DRAWN. BECAUSE THE DEVICE REMAINS IMPLANTED, NO EVALUATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN 2007, A STENTING PROCEDURE TO TREAT INTRACRANIAL ATHEROSCLEROTIC DISEASE IN THE LEFT MIDDLE CEREBRAL ARTERY UNDER HDE (HUMANITARIAN DEVICE EXEMPTION) DESIGNATION. PRE-PROCEDURE STENOSIS IS UNKNOWN. PREDILATION WITH A BALLOON CATHETER WAS PERFORMED, FOLLOWED BY IMPLANTATION OF THE SUBJECT DEVICE (STENT). RESIDUAL STENOSIS IS UNKNOWN. THE "...PATIENT DEVELOPED AN INTRACRANIAL HEMORRHAGE DURING THE PROCEDURE. VESSEL PERFORATION WAS REPORTED DURING STENT PLACEMENT. PATIENT WAS TREATED WITH MEDICATIONS. PATIENT DIED IN 2006."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE - STENT, INTRACRANIAL NEUROVASCULAR NJE NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION WS025015 8010650

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death GATEWAY PTA BALLOON CATHETER