BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM STENT

    MDR report key: 1655623 · Received April 9, 2010

    Report

    Report Number
    2939204-2010-00621
    Event Type
    Death
    Date Received
    April 9, 2010
    Date of Event
    October 20, 2006
    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

    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 SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF THE RUPTURED BILOBED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE ANEURYSM WAS OCCLUDED AND THE PARENT VESSEL WAS PATENT WITH NORMAL FLOW. HOWEVER, THE PATIENT CONDITION CONTINUED TO DECLINE. IMAGING SHOWED INCREASING OF INTRACEREBRAL HEMORRHAGE (ICH), EDEMA, AND HYDROCEPHALUS. TWO DAYS POST PROCEDURE ANOTHER RIGHT FRONTAL VENTRICULOSTOMY TUBE WAS PLACED TO REDUCE THE INTRACRANIAL PRESSURE. THE PATIENT DEVELOPED AN ARTERIAL FIBRILLATION AND A NEW ANTERIOR CEREBRAL ARTERY INFARCT. INTRACRANIAL PRESSURES (ICP) GRADUALLY INCREASED WITH ICP VALUES IN THE LOW 60S. THE PATIENT'S NEUROLOGICAL CONDITION CONTINUED TO DECLINE WITH A GLASGOW COMA SCALE OF 3. THE PATIENT DEVELOPED PNEUMONIA. FOURTEEN DAYS POST PROCEDURE, THE PATIENT STATUS WAS CHANGED TO ¿DO NOT RESUSCITATE (DNR)¿ AND HE WAS EXTUBATED. THE NEXT DAY, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED AS ICH. THE PHYSICIAN STATED THAT THERE WERE NO ISSUES WITH THE STENT PLACEMENT AND ¿THE STENT WAS SEEN TO PLAY ONLY A POSITIVE ROLE IN THE PATIENT¿S CARE¿.

    Description of Event or Problem · 1

    FOLLOWING THE SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF THE RUPTURED BILOBED ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, THE ANEURYSM WAS OCCLUDED AND THE PARENT VESSEL WAS PATENT WITH NORMAL FLOW. HOWEVER, THE PATIENT CONDITION CONTINUED TO DECLINE. IMAGING SHOWED INCREASING OF INTRACEREBRAL HEMORRHAGE (ICH), EDEMA, AND HYDROCEPHALUS. TWO DAYS POST PROCEDURE, ANOTHER RIGHT FRONTAL VENTRICULOSTOMY TUBE WAS PLACED TO REDUCE THE INTRACRANIAL PRESSURE. THE PATIENT DEVELOPED AN ARTERIAL FIBRILLATION AND A NEW ANTERIOR CEREBRAL ARTERY INFARCT. INTRACRANIAL PRESSURES (ICP) GRADUALLY INCREASED WITH ICP VALUES IN THE LOW 60S. THE PATIENT'S NEUROLOGICAL CONDITION CONTINUED TO DECLINE WITH A GLASGOW COMA SCALE OF 3. THE PATIENT DEVELOPED PNEUMONIA. FOURTEEN DAYS POST PROCEDURE, THE PATIENT STATUS WAS CHANGED TO ¿DO NOT RESUSCITATE (DNR)¿ AND HE WAS EXTUBATED. THE NEXT DAY THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED AS ICH. THE PHYSICIAN STATED THAT THERE WERE NO ISSUES WITH THE STENT PLACEMENT, AND ¿THE STENT WAS SEEN TO PLAY ONLY A POSITIVE ROLE IN THE PATIENT¿S CARE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT UNK269

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death GDC COIL (BOSTON SCIENTIFIC)| FIVE THOUSAND UNITS OF HEPARIN| MAVERICK BALLOON CATHETER (BOSTON SCIENTIFIC)| TWO HYDROCOILS (TERUMO)| ECHELON-10 MICROCATHETER(EV3)| FLOPPY-300 TRANSCEND GUIDEWIRE (BOSTON SCIENTIFIC)