BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROFORM STENT

    MDR report key: 1656761 · Received April 12, 2010

    Report

    Report Number
    2939204-2010-00623
    Event Type
    Death
    Date Received
    April 12, 2010
    Date of Event
    December 29, 2007
    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 HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 1

    DEATH DATE: THE PATIENT EXPIRED IN 2007.

    Description of Event or Problem · 1

    THE NEXT DAY POST ADMISSION, THE PATIENT UNDERWENT SUCCESSFUL STENT ASSISTED COIL EMBOLIZATION OF THE RIGHT RUPTURED POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM WITH EXCELLENT FLOW RESTORATION. POST PROCEDURE THE PATIENT¿S NEUROLOGICAL STATUS IMPROVED; HOWEVER, THE PULMONARY STATUS CONTINUED TO DECLINE. THE PATIENT DEVELOPED HEART AND RESPIRATORY FAILURE. IMAGING REVEALED A SUBARACHNOID HEMORRHAGE (SAH). NINE DAYS POST PROCEDURE FOLLOWING THE FAMILY DECISION TO ¿DO NOT RESUSCITATE (DNR)¿, THE PATIENT WAS EXTUBATED. THE PATIENT¿S CONDITION CONTINUED TO DETERIORATE. THE PATIENT¿S BECAME LETHARGIC, NEUROLOGICALLY AND MENTALLY DECLINED, RESPIRATORY STATUS WORSENED OVER THE NEXT NINE DAYS. THE FAMILY MADE THE DECISION OF COMFORT MEASURES ONLY AND THE PATIENT EXPIRED NINETEEN DAYS POST PROCEDURE. THE CAUSE OF DEATH WAS ¿DUE TO THE PATIENT'S BASELINE DISEASE COUPLED WITH MULTIPLE CO MORBIDITIES IN THIS OCTOGENARIAN.¿

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003SNF345150 9345997

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death