BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1893905 · Received November 9, 2010

    Report

    Report Number
    1016427-2010-00137
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 30, 2008
    Report Date
    October 12, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INSPECTION. INFORMATION WAS RECEIVED VIA THE AFFILIATE REGARDING A JAPANESE PUBLICATION PERTAINING TO NEUROLOGICAL SYMPTOMS DURING A LEFT INTERNAL CAROTID ARTERY (ICA) STENTING USING AN ANGIOGUARD EMBOLIC PROTECTION DEVICE AND IMPLANTATION OF A PRECISE STENT. ADDITIONALLY IN-STENT THROMBOSIS WITH DIAGNOSIS OF MULTIPLE LEFT HEMISPHERIC INFARCTS WAS REPORTED THREE WEEKS POST INDEX PROCEDURE. THE INTRA PROCEDURE SYMPTOMS FULLY RESOLVED. WITH MEDICATION AND TWO WEEKS AFTER THE IN-STENT THROMBOSIS, ECHOCARDIOGRAM WAS NEGATIVE FOR THROMBOSES. AT INDEX PROCEDURE THE (B)(6) FEMALE HAD A HISTORY OF BILATERAL STENOSIS. THE PATIENT WAS ASYMPTOMATIC WITH AN 85% STENOSIS IN THE LEFT INTERNAL ICA. THERE IS NO INFORMATION REGARDING THE VESSEL CHARACTERISTICS OR PROCEDURAL DETAILS. DURING THE PROCEDURE THE PATIENT EXPERIENCED DISTURBANCE OF CONSCIOUSNESS, RIGHT HEMIPARESIS, AND APHASIA. THESE SYMPTOMS WERE FULLY RESOLVED IN TEN MINUTES. GOOD DILATATION OF THE LESION WAS OBTAINED. THERE IS NO INFORMATION AVAILABLE REGARDING THE TARGET SITE OR LESION CHARACTERISTICS AND NO FURTHER PROCEDURAL INFORMATION. AN MRI AFTER THE INDEX PROCEDURE WAS NEGATIVE FOR ANY ACUTE INFARCTS. ANTIPLATELET THERAPY INCLUDED ASPIRIN (100 MG/DAY) AND CILOSTAZOL (200 MG/DAY) AT DISCHARGE FROM INDEX PROCEDURE. APPROXIMATELY THREE WEEKS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED DISTURBANCE OF CONSCIOUSNESS, RIGHT HEMIPARESIS AND HEMINEGLECT. CAROTID ECHOGRAM REVEALED THE IN-STENT THROMBOSIS. ARGATROBAN (2.5 ML/HOUR), OZAGREL (80 MG × 2 /DAY), AND CLOPIDOGREL (75 MG/DAY) WERE ADMINISTERED. NEXT DAY, A MRI SHOWED MULTIPLE LEFT HEMISPHERIC INFARCTS. SYMPTOMS WERE FULLY RESOLVED BY MEDICATION AND A CAROTID ECHOGRAM 2 WEEKS AFTER THE STROKE WAS NEGATIVE FOR THROMBOSES. NO FURTHER INFORMATION IS AVAILABLE AND IT WAS REPORTED THAT THE THERE IS NO ENGLISH VERSION OF THE ARTICLE, IT IS ONLY AVAILABLE IN JAPANESE. THE ANGIOGUARD IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. THE STENT REMAINS IMPLANTED AND THE LOT NUMBER IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. NEUROLOGICAL SYMPTOMS ARE WELL KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. THERE ARE SEVERAL FACTORS THAT CAN INFLUENCE THESE EVENTS. ANTICIPATED SHORT TERM ADVERSE EVENTS ASSOCIATED WITH BARO-RECEPTOR TRAUMA THAT IS INTRINSIC TO THE CAROTID ARTERY MANIPULATION DURING DEVICE MANIPULATION, BALLOON INFLATION, AND STENT IMPLANTATION IS A POSSIBLE CAUSE. CERTAIN FACTORS MAY INFLUENCE THE LIKELIHOOD OF ANTICIPATED BARO-RECEPTOR REACTIONS SUCH AS VESSEL/LESION CHARACTERISTICS AND LOCATION, VENTRICULAR DYSFUNCTION, AND PROCEDURAL FACTORS. DISRUPTION OF PERFUSION OR SLOWING OF BLOOD FLOW DUE TO DISLODGEMENT OF DEBRIS FROM PHYSICAL MANIPULATION IS ALSO A WELL KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PROCEDURE. BASED ON THE LACK OF PROCEDURAL INFORMATION AND THE TIMING OF THE INTRA-PROCEDURAL NEUROLOGICAL CHANGES AS RELATED TO THE PROCEDURAL STEPS, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP TO THE DEVICES; HOWEVER, POSSIBLE CONTRIBUTING FACTORS INCLUDE PATIENT, VESSEL AND PROCEDURAL FACTORS. THROMBOSIS IN DEVICE AND ISCHEMIC STROKE ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THE PATIENT WAS MAINTAINED ON AN ASA AND PLAVIX REGIMEN AS PER THE IFU. HOWEVER PATIENT RESPONSIVENESS AND OTHER UNDERLYING FACTORS MAY HAVE CONTRIBUTED. BASED ON THE LIMITED INFORMATION, NO CONCLUSION CAN BE MADE. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENTS, THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #9616099-2010-00855 AND #1016427-2010-00137. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT WAS RECEIVED FROM THE AFFILIATE THROUGH A LITERATURE SEARCH. THE ARTICLE WAS PUBLISHED IN THE ABSTRACT JOURNAL OF 34TH CONGRESS OF THE JAPAN STROKE SOCIETY (STROKE2009), WHICH WAS HELD ON MARCH 20TH, 2009-MARCH 22TH, 2009 IN JAPAN. THE ARTICLE WAS NOT PROVIDED AND IS NOT AVAILABLE. THE REPORT INDICATED THAT THE PATIENT HAD BILATERAL CAROTID STENOSIS AND WAS ASYMPTOMATIC. DURING THE INTERVENTIONAL INDEX PROCEDURE FOR CAROTID ARTERY STENT IMPLANTATION (CAS) USING AN UNKNOWN PRECISE STENT AND AN UNKNOWN ANGIOGUARD EMBOLIC PROTECTION DEVICE, THE PATIENT EXPERIENCED A DISTURBANCE OF CONSCIOUSNESS CHARACTERIZED BY RIGHT HEMIPARESIS AND APHASIA. THE TARGET LESION FOR THE PROCEDURE WAS AN 85% LEFT INTERNAL CAROTID ARTERY (LICA) STENOSIS. THE PATIENT'S SYMPTOMS FULLY RESOLVED IN TEN MINUTES. A GOOD DILATION OF THE LESION WAS OBTAINED. AN MRI AFTER THE PROCEDURE WAS NEGATIVE FOR ANY ACUTE INFARCTS. THE PATIENT WAS DISCHARGED ON ANTIPLATELET THERAPY. APPROXIMATELY THREE WEEKS AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A DISTURBANCE OF CONSCIOUSNESS CHARACTERIZED BY RIGHT HEMIPARESIS AND HEMINEGLECT. A CAROTID ANGIOGRAM REVEALED IN-STENT-THROMBOSIS OF THE PREVIOUSLY IMPLANTED PRECISE STENT. MEDICATIONS WERE ADMINISTERED. THE NEXT DAY, AN MRI SHOWED MULTIPLE LEFT HEMISPHERIC INFARCTIONS. THE PATIENT'S SYMPTOMS WERE FULLY RESOLVED WITH MEDICATIONS. A CAROTID ULTRASOUND TWO WEEKS AFTER THE ADVERSE EVENT WAS NEGATIVE FOR THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE NTE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L PRECISE CAROTID STENT