BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5189022 · Received October 29, 2015

    Report

    Report Number
    1226348-2015-00065
    Event Type
    Injury
    Date Received
    October 29, 2015
    Date of Event
    May 26, 2015
    Report Date
    October 12, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE LITERATURE ARTICLE ¿ENDOVASCULAR TREATMENT OF DISSECTING ANEURYSMS OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY AND PREDICTORS OF OUTCOME¿ BY HUI LI, PHD, XI-FENG LI, PHD, XU-YING HE, PHD, XIN ZHANG, PHD, GUO-HUI ZHU, PHD, QIN-RUI FANG, MD, ZE-QUN WANG, MD, AND CHUAN-ZHI DUAN, PHD, PUBLISHED IN JOURNAL OF STROKE AND CEREBROVASCULAR DISEASES, VOL. 24, NO. 9 (SEPTEMBER), 2015: PP 2134-2142, IT WAS REPORTED THAT ONE PATIENT WHO RECEIVED STENT ASSISTED COIL EMBOLIZATION WITH AN ENTERPRISE STENT (DETAILS UNKNOWN) HAD IN-STENT STENOSIS AT THE FOLLOW UP VISIT. THE ARTICLE DISCUSSES ISOLATED DISSECTING ANEURYSMS OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ARE RARE LESIONS, WHICH CARRY HIGH RISK OF RE-BLEEDING AND MORTALITY. HOWEVER, THE EXISTING LITERATURE CONCERNING PREDICTORS OF OUTCOME AFTER ENDOVASCULAR TREATMENT IS LIMITED AND CONTROVERSIAL. OUR PRESENT STUDY RETROSPECTIVELY REVIEWED AND ANALYZED THE CLINICAL OUTCOME OF ENDOVASCULAR TREATMENT¿RUPTURED PICA-DISSECTING ANEURYSMS AND EXPLORED THE PREDICTORS OF OUTCOME. AFTER AN OPTIMAL ANGIOGRAPHIC PROJECTION WAS ACHIEVED, A MICROCATHETER (DETAILS UNKNOWN) WAS DIRECTED INTO THE LESION THROUGH THE GUIDEWIRE (DETAILS UNKNOWN). COILS (DETAILS UNKNOWN) WERE PLACED THROUGH THE MICROCATHETER INTO THE ANEURYSM AND DETACHED UNDER FLUOROSCOPY. PARENT ARTERY OCCLUSION (PVO) WAS ALSO PERFORMED WITH COILS, BUT BALLOON TEXT OCCLUSION WAS NOT PERFORMED IN PATIENTS TREATED WITH PVO. HOWEVER, THE CAPABILITY OF THE PATIENT TO TOLERATE PICA OCCLUSION WAS ASSESSED IN DIAGNOSTIC ANGIOGRAM BASED ON THE PRESENCE AND SIZE OF POTENTIALS COLLATERAL VESSELS, SUCH AS CONTRALATERAL PICA, IPSILATERAL ANTERIOR INFERIOR CEREBELLAR ARTERY, AND SUPERIOR CEREBELLAR ARTERY. THE STENT WAS DEPLOYED TO COVER THE WHOLE DISSECTING SEGMENT. SEVERAL TYPES OF COILS WERE USED (GDC OR MATRIX; BOSTON SCIENTIFIC CORPORATION, (B)(4), AND EDC; EV3 NEUROVASCULAR, IRVINE, CA) AND CONSISTED OF THE ENTERPRISE STENT (CORDIS CORPORATION, MIAMI LAKE, FL). AFTER THE PROCEDURE, PATIENTS WERE CONTINUOUSLY MONITORED FOR 24 HOURS IN OUR NEUROSURGERY INTENSIVE CARE UNIT. THE PATIENT WHO UNDERWENT STENT ASSISTED COILING RECEIVED CLOPIDOGREL AND ASPIRIN FOR 3 MONTHS; AFTER 3 MONTHS, ASPIRIN ALONE WAS ADMINISTERED FOR 1 YEAR. THE ONLY PATIENT WITH STENT-ASSISTED COILING DEVELOPED PICA OCCLUSION DURING THE 1-MONTH FOLLOW-UP, AND THE TERRITORY OF ARTERY DISTAL TO ANEURYSM WAS FILLED BY BILATERAL ANTERIOR INFERIOR CEREBELLAR ARTERY. AT THE TIME OF COMPLAINT ENTRY THERE IS NO CATALOGUE OR STERILE LOT NUMBER INFORMATION AVAILABLE. NEITHER THE CATALOGUE NUMBER NOR THE LOT NUMBER WAS AVAILABLE THUS NEITHER DHR NOR FAL COULD BE COMPLETED. IN-STENT STENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD IN THE TREATMENT OF CEREBRAL ANEURYSMS AND IS LISTED IN THE IFU AS SUCH. NO DHR OR FAL COULD BE DONE AS THERE WAS NO STERILE LOT NUMBER AND THE DEVICE REMAINED IMPLANTED; HOWEVER, ALL DEVICES UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR MARKETING. OVER GROWTH OF THE INTRAVASCULAR ENDOTHELIUM IS A KNOWN PHENOMENON ASSOCIATED WITH THE USE OF ALL VASCULAR STENTS. MULTIPLE FACTORS CAN CONTRIBUTE TO THE DEVELOPMENT OF IN-STENT STENOSIS, I.E. INITIAL DAMAGE TO THE VESSEL UPON DEPLOYMENT OF THE STENT, INFLAMMATORY RESPONSE OF THE PATIENT AFTER THE IMPLANTATION, LOCATION AND CHARACTERISTICS OF THE TREATED VESSEL AND POST-PROCEDURE MEDICATION REGIMEN. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS ALL OF THOSE FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS IS AN INITIAL/FINAL REPORT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: MICROCATHETER (DETAILS UNKNOWN) GUIDEWIRE (DETAILS UNKNOWN) COILS (DETAILS UNKNOWN) GDC OR MATRIX; BOSTON SCIENTIFIC CORPORATION, (B)(4), AND EDC; EV3 NEUROVASCULAR.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE "ENDOVASCULAR TREATMENT OF DISSECTING ANEURYSMS OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY AND PREDICTORS OF OUTCOME" BY HUI LI, PHD, XI-FENG LI, PHD, XU-YING HE, PHD, XIN ZHANG, PHD, GUO-HUI ZHU, PHD, QIN-RUI FANG, MD, ZE-QUN WANG, MD, AND CHUAN-ZHI DUAN, PHD, PUBLISHED IN JOURNAL OF STROKE AND CEREBROVASCULAR DISEASES, VOL. 24, NO. 9 (SEPTEMBER), 2015: PP 2134-2142, IT WAS REPORTED THAT ONE PATIENT WHO RECEIVED STENT ASSISTED COIL EMBOLIZATION WITH AN ENTERPRISE STENT (DETAILS UNKNOWN) HAD IN-STENT STENOSIS AT THE FOLLOW UP VISIT. THE ARTICLE DISCUSSES ISOLATED DISSECTING ANEURYSMS OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) ARE RARE LESIONS, WHICH CARRY HIGH RISK OF REBLEEDING AND MORTALITY. HOWEVER, THE EXISTING LITERATURE CONCERNING PREDICTORS OF OUTCOME AFTER ENDOVASCULAR TREATMENT IS LIMITED AND CONTROVERSIAL. OUR PRESENT STUDY RETROSPECTIVELY REVIEWED AND ANALYZED THE CLINICAL OUTCOME OF ENDOVASCULAR TREATMENT-RUPTURED PICA-DISSECTING ANEURYSMS AND EXPLORED THE PREDICTORS OF OUTCOME. AFTER AN OPTIMAL ANGIOGRAPHIC PROJECTION WAS ACHIEVED, A MICROCATHETER (DETAILS UNKNOWN) WAS DIRECTED INTO THE LESION THROUGH THE GUIDEWIRE (DETAILS UNKNOWN). COILS (DETAILS UNKNOWN) WERE PLACED THROUGH THE MICROCATHETER INTO THE ANEURYSM AND DETACHED UNDER FLUOROSCOPY. PARENT ARTERY OCCLUSION (PVO) WAS ALSO PERFORMED WITH COILS, BUT BALLOON TEXT OCCLUSION WAS NOT PERFORMED IN PATIENTS TREATED WITH PVO. HOWEVER, THE CAPABILITY OF THE PATIENT TO TOLERATE PICA OCCLUSION WAS ASSESSED IN DIAGNOSTIC ANGIOGRAM BASED ON THE PRESENCE AND SIZE OF POTENTIALS COLLATERAL VESSELS, SUCH AS CONTRALATERAL PICA, IPSILATERAL ANTERIOR INFERIOR CEREBELLAR ARTERY, AND SUPERIOR CEREBELLAR ARTERY. THE STENT WAS DEPLOYED TO COVER THE WHOLE DISSECTING SEGMENT. SEVERAL TYPES OF COILS WERE USED (GDC OR MATRIX; BOSTON SCIENTIFIC CORPORATION, (B)(4), AND EDC; EV3 NEUROVASCULAR, IRVINE, CA) AND CONSISTED OF THE ENTERPRISE STENT (CORDIS CORPORATION, MIAMI LAKE, FL). AFTER THE PROCEDURE, PATIENTS WERE CONTINUOUSLY MONITORED FOR 24 HOURS IN OUR NEUROSURGERY INTENSIVE CARE UNIT. THE PATIENT WHO UNDERWENT STENT ASSISTED COILING RECEIVED CLOPIDOGREL AND ASPIRIN FOR 3 MONTHS; AFTER 3 MONTHS, ASPIRIN ALONE WAS ADMINISTERED FOR 1 YEAR. THE ONLY PATIENT WITH STENT-ASSISTED COILING DEVELOPED PICA OCCLUSION DURING THE 1-MONTH FOLLOW-UP, AND THE TERRITORY OF ARTERY DISTAL TO ANEURYSM WAS FILLED BY BILATERAL ANTERIOR INFERIOR CEREBELLAR ARTERY. AT THE TIME OF COMPLAINT ENTRY THERE IS NO CATALOGUE OR STERILE LOT NUMBER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717060 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1