BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM STENT

    MDR report key: 1656485 · Received April 12, 2010

    Report

    Report Number
    2939204-2010-00620
    Event Type
    Death
    Date Received
    April 12, 2010
    Date of Event
    March 15, 2010
    Report Date
    March 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    CONCLUSION: FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED, THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. DEATH IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    FOLLOWING THE PROCEDURE THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL AND UNCOMPLICATED STENT ASSISTED COIL EMBOLIZATION OF THE RUPTURED GIANT UPPER BASILAR ANEURYSM AND RIGHT FRONTAL VENTRICULOSTOMY SHUNT PLACEMENT TO REDUCE THE INTRACRANIAL PRESSURE. POST PROCEDURE, THE PATIENT¿S CONDITION CONTINUED TO DECLINE. SIX DAYS POST PROCEDURE, THE PATIENT SUFFERED A NEW POSTERIOR FOSSA STROKE AND AN INCREASE IN THE SUBARACHNOID AND INTRAVENTRICULAR BLOOD. THE PATIENT¿S CONDITION WAS COMPLICATED BY A MILD OBSTRUCTIVE HYDROCEPHALUS, INTRACRANIAL PRESSURE SPIKES, HYPOXIA, HYPERTENSION, AND BRADYCARDIA. ELEVEN DAYS POST PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS RELATED TO THE PRESENTING RUPTURED BASILAR ANEURYSM AND ASSOCIATED SUBARACHNOID HEMORRHAGE (SAH) AND CEREBRAL EDEMA.

    Description of Event or Problem · 1

    FOLLOWING THE PROCEDURE THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003SNF340300 13234246

    Patients

    Seq Age Sex Outcome Treatment
    1 Death