BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM STENT

    MDR report key: 1656974 · Received April 12, 2010

    Report

    Report Number
    2939204-2010-00652
    Event Type
    Death
    Date Received
    April 12, 2010
    Date of Event
    May 11, 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

    DEATH DATE: THE PATIENT EXPIRED IN 2007.

    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 AND THE EXACT DAY IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    FOLLOWING THE SUCCESSFUL REMOVAL OF THE THROMBUS USING A RETRIEVAL DEVICE, A STENT WAS UNEVENTFULLY PLACED IN THE BASILAR ARTERY (BA) NORMALIZING FLOW AND RESTORING SMOOTH LUMINAL MARGINS. HOWEVER, DESPITE REVASCULARIZATION OF THE BA, THE PATIENT FAILED TO WAKE UP AND DEVELOPED A HERNIATION SYNDROME OVER THE NEXT 24 HOURS POST PROCEDURE. THE PATIENT SUFFERED MULTIPLE STROKES IN THE POSTERIOR CIRCULATION IN THE BRAINSTEM, OCCIPITAL LOBES AND CEREBELLUM. ONE DAY POST PROCEDURE, THE PATIENT LOST ALL CRANIAL NERVE REFLEXES AND WAS DECLARED CLINICALLY BRAIN DEAD. THE PATIENT¿S FAMILY WITHDREW THE SUPPORT AND THE PATIENT EXPIRED TWO DAYS POST PROCEDURE. THE CAUSE OF DEATH WAS DUE TO A CONSEQUENCE OF THE PRE-EXISTING VESSEL DISSECTION THAT RESULTED IN MULTIPLE ISCHEMIC STROKES AND CEREBRAL EDEMA. THE PHYSICIAN STATED THAT THERE WERE NO ISSUES WITH THE STENT PLACEMENT AND ¿THE STENT WAS FELT TO HAVE MADE A POSITIVE CONTRIBUTION 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 53 YR Death