BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM2 MICRODELIVERY STENT SYSTEM

    MDR report key: 795675 · Received December 13, 2006

    Report

    Report Number
    6000078-2006-00593
    Event Type
    Death
    Date Received
    December 13, 2006
    Date of Event
    August 9, 2006
    Report Date
    November 21, 2006
    Manufacturer
    NEUROVASCULAR, DIV. OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    NJE
    PMA / PMN Number
    see h10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D7. EXPLANTED DATE: AS THIS DEVICE WAS IMPLANTED INTO THE PATIENT AND THE PATIENT EXPIRED, THIS FIELD IS NOT APPLICABLE. G.5=PMA/510/K: H020002/S4, H020002/S5. THE DEVICE IN QUESTION WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS IT WAS IMPLANTED INTO THE PATIENT, AND THE PATIENT EXPIRED. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE PATIENT'S DEATH. IN ADDITION, BECAUSE NO BATCH NUMBER WAS GIVEN, BOSTON SCIENTIFIC WAS UNABLE TO PERFORM A REVIEW OF THE DEVICE HISTORY RECORD OR A SIMILAR COMPLAINT REVIEW. IF ANY FURTHER, SIGNIFICANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL FOLLOW. UNTIL, SUCH TIME ADDITIONAL INFORMATION IS RECEIVED, BOSTON SCIENTIFIC WILL CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THE PATIENT WAS UNDERGOING AN EMBOLIZATION OF A WIDE NECK BASILAR APEX ANEURYSM WHICH REQUIRED "Y" STENTING WITH TWO INTRACRANIAL STENTS. THE PHYSICIAN REPORTED HE ATTEMPTED TO PLACE A NON-BOSTON SCIENTIFIC COIL, HOWEVER THE COIL FAILED TO DETACH AND FRACTURED. THE LOOSE COIL WAS TACKED UP AGAINST THE VESSEL WALL WITH A THIRD INTRACRANAIL STENT. THE PROCEDURE WAS REPORTEDLY SUCCESSFUL. THE PATIENT REPORTEDLY WOKE UP WITH NO PROBLEM. HOWEVER, IN ICU, THE PATIENT WAS FOUND TO BE OVER ANTI-COAGULATED AND HEMORRHAGED. THE PATIENT'S LIFE SUPPORT WAS TERMINATED THE FOLLOWING DAY. NO FURTHER INFORMATION WAS DISCLOSED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM2 MICRODELIVERY STENT SYSTEM (NJE) INTRACRANIAL STENT NJE NEUROVASCULAR, DIV. OF BOSTON SCIENTIFIC CORPORATION S240020 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death