BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROFORM 3 EZ- 4.5 X 30MM

    MDR report key: 3022051 · Received March 26, 2013

    Report

    Report Number
    3008853977-2013-00055
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC CORK, LTD
    Product Code
    NJE
    PMA / PMN Number
    H020002
    Adverse Event
    Yes
    Product Problem
    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 SUBJECT DEVICE WAS IMPLANTED; THEREFORE ANALYSIS CANNOT BE PERFORMED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S TORTUOUS ANATOMY CONTRIBUTED TO THE UNINTENDED MOVEMENT OF THE STENT DELIVERY SYSTEM RESULTING IN THE UNINTENDED DEPLOYMENT OF THE STENT. ALTHOUGH, THE PHYSICIAN ASSESSMENT OF THE PATIENT'S OUTCOME POST PROCEDURE INDICATED THAT IT MAY BE RELATED TO GUIDE CATHETER MANIPULATION; IT SHOULD BE NOTED THAT STROKE AND THROMBOSIS ARE KNOWN RISK ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND NOTED AS SUCH IN THE DIRECTIONS FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION HAS BEEN ASSIGNED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENT ASSISTED COILING EMBOLIZATION OF A LEFT CAVERNOUS ANEURYSM, UNINTENDED MOVEMENT OF THE DELIVERY SYSTEM OCCURRED RESULTING IN SUB-OPTIMAL DEPLOYMENT OF THE STENT OVER THE TARGET LESION. THEREFORE, THE PHYSICIAN DEPLOYED A SECOND STENT. MAGNETIC RESONANCE IMAGING (MRI) PERFORMED APPROXIMATELY 48 HOURS POST PROCEDURE REVEALED THAT THE PATIENT HAD DEVELOPED AN ASYMPTOMATIC CEREBRAL INFARCTION IN THE LEFT 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 DURING A STENT ASSISTED COILING EMBOLIZATION OF A LEFT CAVERNOUS ANEURYSM, UNINTENDED MOVEMENT OF THE DELIVERY SYSTEM OCCURRED RESULTING IN SUB-OPTIMAL DEPLOYMENT OF THE STENT OVER THE TARGET LESION. THEREFORE, THE PHYSICIAN DEPLOYED A SECOND STENT. MAGNETIC RESONANCE IMAGING (MRI) PERFORMED APPROXIMATELY 48 HOURS POST PROCEDURE REVEALED THAT THE PATIENT HAD DEVELOPED AN ASYMPTOMATIC CEREBRAL INFARCTION IN THE LEFT 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
    123409 NEUROFORM 3 EZ- 4.5 X 30MM STENT, INTRACRANIAL NEUROVASCULAR NJE BOSTON SCIENTIFIC CORK, LTD 15260671

    Patients

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