BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 EZ- 4.5 X 20MM

    MDR report key: 3022070 · Received March 26, 2013

    Report

    Report Number
    3008853977-2013-00054
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS IMPLANTED; THEREFORE ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT THE REPORTED EVENT IS RELATED TO PRODUCT SPECIFICATIONS NONCONFORMANCE OR MISUSE. THERE IS ALSO NO INDICATION THAT THE SUBJECT DEVICE MALFUNCTIONED. HOWEVER, STROKE AND VESSEL THROMBOSIS ARE KNOWN COMPLICATIONS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 24 HOURS POST SUCCESSFUL STENT ASSISTED COILING EMBOLIZATION OF A LEFT CAVERNOUS SINUS ANEURYSM; THE MAGNETIC RESONANCE IMAGING (MRI) REVEALED THAT THE PATIENT HAD DEVELOPED AN ASYMPTOMATIC CEREBRAL INFARCTION IN THE RIGHT FRONTAL LOBE. NO TREATMENT WAS ADMINISTERED IN RESPONSE TO THE REPORTED FINDING, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PHYSICIAN INFORMED THAT A "BLOOD CLOT" MAY HAVE DEVELOPED DUE TO A LOT OF MANIPULATION OF THE GUIDE CATHETER TO REACH THE TARGET LESION. THE RELATIONSHIP BETWEEN THE STENT AND THE ASYMPTOMATIC CEREBRAL INFARCTION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 24 HOURS POST SUCCESSFUL STENT ASSISTED COILING EMBOLIZATION OF A LEFT CAVERNOUS SINUS ANEURYSM; THE MAGNETIC RESONANCE IMAGING (MRI) REVEALED THAT THE PATIENT HAD DEVELOPED AN ASYMPTOMATIC CEREBRAL INFARCTION IN THE RIGHT FRONTAL LOBE. NO TREATMENT WAS ADMINISTERED IN RESPONSE TO THE REPORTED FINDING, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PHYSICIAN INFORMED THAT A "BLOOD CLOT" MAY HAVE DEVELOPED DUE TO A LOT OF MANIPULATION OF THE GUIDE CATHETER TO REACH THE TARGET LESION. THE RELATIONSHIP BETWEEN THE STENT AND THE ASYMPTOMATIC CEREBRAL INFARCTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124513 NEUROFORM 3 EZ- 4.5 X 20MM STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC CORK, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GUIDE CATHETER (ASAHI INTECC)