BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM MICRODELIVERY STENT SYSTEM

    MDR report key: 948980 · Received November 16, 2007

    Report

    Report Number
    6000078-2007-00301
    Event Type
    Death
    Date Received
    November 16, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NJE
    PMA / PMN Number
    H020002/S4
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K) # IS H020002/S5. PRODUCT ANALYSIS CANNOT BE PERFORMED BY THE MANUFACTURER AS THE DEVICE IN QUESTION REMAINS IMPLANTED IN THE PATIENT. NO ALLEGED MALFUNCTION HAS BEEN REPORTED ON THE STENT. IT IS UNKNOWN WHEN AND WHERE THE BLEEDING FIRST OCCURRED. SEVERAL ATTEMPTS HAVE BEEN MADE TO REQUEST FOR ADDITIONAL INFORMATION ON PRODUCT INFORMATION AND EVENT DESCRIPTION, BUT AS OF CURRENT NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE FOR THE MANUFACTURER'S REVIEW.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO THE MANUFACTURER: WHILE ATTEMPTING TO COIL AN ANEURYSM THROUGH THE MANUFACTURER'S STENT, THE PHYSICIAN NOTICED THAT THE PATIENT WAS BLEEDING UNDER FLUOROSCOPY. PROCEDURE WAS NOT COMPLETED, AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM MICRODELIVERY STENT SYSTEM NJE: STENT (INTRACRANIAL NEUROVASCULAR) NJE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death