BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM EZ® 3

    MDR report key: 2761243 · Received September 26, 2012

    Report

    Report Number
    2939204-2012-00287
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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. THROMBOSIS, STROKE AND HEMORRHAGE DEFICIT 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

    (B)(6) DAYS POST BASILAR ANEURYSM Y-STENTING PROCEDURE, THE PATIENT PRESENTED WITH 8 HOURS OF POSTERIOR CIRCULATION AND BRAIN STEM STROKE ONSET. IMAGING SHOWED BASILAR ARTERY (BA) THROMBOSIS DISTAL TO THE STENTS. THE PATIENT WAS GIVEN 21 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) INTRAARTERIALLY AND SUCCESSFUL BA RECANALIZATION WAS ACHIEVED. HOWEVER, LATER THE SAME DAY AND THE NEXT DAY IMAGING FOUND POSSIBLE HEMORRHAGIC TRANSFORMATION AND EDEMA OF THE POSTERIOR CEREBRAL ARTERY TERRITORY INFARCT WITH LIMITED BLOOD FLOW. THE PATIENT CURRENTLY IS IN INTENSIVE CARE IN CRITICAL CONDITION AT HIGH RISK OF DECOMPENSATION.

    Description of Event or Problem · 1

    AT 20 DAYS POST BASILAR ANEURYSM Y-STENTING PROCEDURE, THE PATIENT PRESENTED WITH 8 HOURS OF POSTERIOR CIRCULATION AND BRAIN STEM STROKE ONSET. IMAGING SHOWED BASILAR ARTERY (BA) THROMBOSIS DISTAL TO THE STENTS. THE PATIENT WAS GIVEN 21 MG OF TISSUE PLASMINOGEN ACTIVATOR (TPA) INTRAARTERIALLY AND SUCCESSFUL BA RECANALIZATION WAS ACHIEVED. HOWEVER, LATER THE SAME DAY AND THE NEXT DAY IMAGING FOUND POSSIBLE HEMORRHAGIC TRANSFORMATION AND EDEMA OF THE POSTERIOR CEREBRAL ARTERY TERRITORY INFARCT WITH LIMITED BLOOD FLOW. THE PATIENT CURRENTLY IS IN INTENSIVE CARE IN CRITICAL CONDITION AT HIGH RISK OF DECOMPENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM EZ® 3 STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - CORK M003N3EZ45300 13497847

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention STENT (MAKE AND MODEL UNKNOWN)