BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM EZ¿ 3

    MDR report key: 2250361 · Received September 15, 2011

    Report

    Report Number
    2939204-2011-00432
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THROMBOSIS AND HEMORRHAGE ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DEVELOPED A THOMBUS IN A BRANCH OFF THE POSTERIOR CEREBRAL ARTERY DURING THE STENT ASSISTED COIL EMBOLIZATION PROCEDURE. REOPRO WAS ADMINISTERED TO TREAT THE THROMBUS. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DEVELOPED A THOMBUS IN A BRANCH OFF THE POSTERIOR CEREBRAL ARTERY AFTER THE STENT WAS IMPLANTED, THERE WAS NO INSTENT THROMBOSIS. REOPRO WAS ADMINISTERED TO TREAT THE THROMBUS AND THE THROMBUS WAS FULLY RESOLVED. THE PATIENT SUFFERED SECONDARY BLEEDING DUE TO THE REOPRO THAT WAS ADMINISTERED TO TREAT THE THROMBUS. NO OTHER INFORMATION REGARDING THE PATIENT'S CONDITION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROFORM EZ¿ 3 STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC - CORK M003N3EZ25150 13872174

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention