BEUDAMED
    FDA Adverse Event Death Summary report: N

    WINGSPAN STENT

    MDR report key: 1716902 · Received June 10, 2010

    Report

    Report Number
    2939204-2010-00749
    Event Type
    Death
    Date Received
    June 10, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION (OTHER): 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. HEMORRHAGE, STROKE AND DEATH ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL ANGIOPLASTY OF THE LEFT A1 ANTERIOR CEREBRAL ARTERY ALONG WITH ANGIOPLASTY AND STENTING OF THE LEFT M1 MIDDLE CEREBRAL ARTERY (MCA) AND DISTAL INTRACRANIAL INTERNAL CAROTID ARTERY SEGMENTS. THE PATIENT AWOKE WELL AND WAS MOVING THE UPPER AND LOWER EXTREMITIES SYMMETRICALLY. HOWEVER, APPROXIMATELY THREE HOURS POST PROCEDURE, THE PATIENT BECAME UNRESPONSIVE. A CT SCAN REVEALED A HEMORRHAGIC TRANSFORMATION OF THE INFARCTION IN HER LEFT PARIETAL REGION; DEMONSTRATING SIGNIFICANT INTRAVENTRICULAR EXTENSION WITH OBSTRUCTIVE HYDROCEPHALUS. THE PATIENT HAD AN EXTERNAL VENTRICULAR DRAIN PLACED TO MEASURE INTRACRANIAL PRESSURE AND TO RELIEVE EXCESS FLUID. THERE WERE NO IMMEDIATE COMPLICATIONS, AND THE PATIENT TOLERATED THE PROCEDURE WELL. HOWEVER, THE INTRACRANIAL PRESSURE INCREASED, AND ON THE FOLLOWING DAY, THE PATIENT WAS DECLARED TO BE BRAIN DEAD. THE PHYSICIAN BELIEVED THE BLEEDING WAS DUE TO A REPERFUSION HEMORRHAGE AND STATED THE REPERFUSION HEMORRHAGE INCLUDED WERNICKE¿S AREA AND PRIMARY SENSORY CORTEX.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT SUCCESSFUL ANGIOPLASTY OF THE LEFT A1 ANTERIOR CEREBRAL ARTERY ALONG WITH ANGIOPLASTY AND STENTING OF THE LEFT M1 MIDDLE CEREBRAL ARTERY (MCA) AND DISTAL INTRACRANIAL INTERNAL CAROTID ARTERY SEGMENTS. THE PATIENT AWOKE WELL AND WAS MOVING THE UPPER AND LOWER EXTREMITIES SYMMETRICALLY. HOWEVER, APPROXIMATELY THREE HOURS POST PROCEDURE, THE PATIENT BECAME UNRESPONSIVE. A CT SCAN REVEALED A HEMORRHAGIC TRANSFORMATION OF THE INFARCTION IN HER LEFT PARIETAL REGION; DEMONSTRATING SIGNIFICANT INTRAVENTRICULAR EXTENSION WITH OBSTRUCTIVE HYDROCEPHALUS. THE PATIENT HAD AN EXTERNAL VENTRICULAR DRAIN PLACED TO MEASURE INTRACRANIAL PRESSURE AND TO RELIEVE EXCESS FLUID. THERE WERE NO IMMEDIATE COMPLICATIONS, AND THE PATIENT TOLERATED THE PROCEDURE WELL. HOWEVER, THE INTRACRANIAL PRESSURE INCREASED, AND ON THE FOLLOWING DAY, THE PATIENT WAS DECLARED TO BE BRAIN DEAD. THE PHYSICIAN BELIEVED THE BLEEDING WAS DUE TO A REPERFUSION HEMORRHAGE AND STATED THE REPERFUSION HEMORRHAGE INCLUDED WERNICKE'S AREA AND PRIMARY SENSORY CORTEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WINGSPAN STENT STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - FREMONT M003WS0300150 12518564

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O| R GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)| APEX MONORAIL CATHETER (BOSTON SCIENTIFIC)