BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2161464 · Received July 14, 2011

    Report

    Report Number
    1058196-2011-00337
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 15, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR INSPECTION. A TOTAL OF TWENTY-ONE (21) COMPLAINTS WERE CREATED TO CAPTURE THE EVENTS IN THIS ARTICLE: SIX EACH (6/21) WERE CAPTURED AS INCOMPLETE EXPANSION; TWELVE (12/21) WERE CAPTURED AS INCOMPLETE EXPANSION WITH CEREBRAL ARTERY EMBOLIZATION; AND THREE (3/21) WERE CAPTURED AS CEREBRAL ARTERY EMBOLIZATION ONLY. INCOMPLETE EXPANSION ONLY: (B)(4). INCOMPLETE EXPANSION WITH CEREBRAL ARTERY EMBOLIZATION: (B)(4). CEREBRAL ARTERY EMBOLIZATION ONLY: (B)(4). THE COMPLAINT RECEIVED STATES THAT THERE WAS INCOMPLETE ENTERPRISE STENT APPOSITION POST IMPLANTATION. AN ARTICLE WAS FOUND DURING A LITERATURE SEARCH: MALEK ET AL IN "CRESCENT SIGN ON MAGNETIC RESONANCE ANGIOGRAPHY REVEALING INCOMPLETE STENT APPOSITION: CORRELATION WITH DIFFUSION-WEIGHTED CHANGES IN STENT-MEDICATED COIL EMBOLIZATION OF ANEURYSMS"; DOI: 10.3171/2011.4.JNS102050. THE ARTICLE REPORTED INCOMPLETE ENTERPRISE STENT APPOSITION ASSOCIATED WITH PERIPROCEDURAL IPSILATERAL LESIONS POST TREATMENT OF UNRUPTURED ANEURYSMS. A DISTINCTIVE SEMILUNAR SIGNAL PATTERN, IDENTIFIED USING 3-T MR ANGIOGRAPHY, REPRESENTED FLOW OUTSIDE THE CONFINES OF THE ENTERPRISE STENT STRUT. THIS PATTERN, DESIGNATED AS THE CRESCENT SIGN, WAS CONFIRMED TO CORRESPOND TO INCOMPLETE STENT APPOSITION BY USE OF HIGH-RESOLUTION ANGIOGRAPHIC FLAT-PANEL CT SCANNING REVEALING FLOW INGRESS INTO AND EGRESS OUT OF THE ISOLATED LUMINAL WEDGE. THE INCOMPLETE STENT APPOSITION WAS ALSO ASSOCIATED WITH PERIPROCEDURAL IPSILATERAL HYPERINTENSE LESIONS ON DIFFUSION WEIGHTED IMAGING. THESE RESULTS IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS. THE PATIENT DID NOT SUFFER ANY IRREVERSIBLE CLINICAL DEFICIT ATTRIBUTED TO THE LESIONS NOTED ON DIFFUSION-WEIGHTED IMAGING BY THE TIME OF DISCHARGE. THE CRESCENT SIGN WAS STRONGLY PREDICTIVE OF IPSILATERAL POSTPROCEDURAL LESIONS SEEN ON DIFFUSION-WEIGHTED IMAGING IN THE ENTIRE POPULATION INCOMPLETE STENT APPOSITION IS DETECTABLE ON 3-T MR ANGIOGRAPHY AS A CRESCENT SIGN, AND WAS FOUND TO BE HIGHLY PREVALENT IN ENTERPRISE CLOSED-CELL DESIGN STENTS USED TO ASSIST COIL EMBOLIZATION OF ANEURYSMS. THE RESULTS OF THE STUDY IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR INSPECTION. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. STENT MALAPPOSITION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. WHILE MALAPPOSITION IS NOT SPECIFICALLY NOTED IN THE ENTERPRISE IFU, INCOMPLETE ANEURYSM OCCLUSION, FAILURE TO DELIVER THE STENT TO THE INTENDED SITE AND STENT THROMBOSIS ARE NOTED. IT IS ALSO NOTED THAT THE ABILITY OF THE ENTERPRISE STENT TO WITHSTAND POST BALLOON DILATION HAS NOT BEEN ESTABLISHED. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL CONFORMATION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PLEASE ALSO NOTE THAT THE LITERATURE ARTICLE FOR THE FOLLOWING MFR REPORTS IS ATTACHED TO (B)(4). REPORT # 1058196-2011-00337 ONLY. PLEASE NOTE THAT THESE ARE THE INITIAL/FINAL REPORTS FOR THESE FILES.

    Description of Event or Problem · 1

    AN ARTICLE WAS FOUND DURING A LITERATURE SEARCH: MALEK ET AL IN "CRESCENT SIGN ON MAGNETIC RESONANCE ANGIOGRAPHY REVEALING INCOMPLETE STENT APPOSITION: CORRELATION WITH DIFFUSION-WEIGHTED CHANGES IN STENT-MEDICATED COIL EMBOLIZATION OF ANEURYSMS"; DOI: 10.3171/2011.4.JNS102050. THE ARTICLE REPORTED INCOMPLETE ENTERPRISE STENT APPOSITION ASSOCIATED WITH PERIPROCEDURAL IPSILATERAL LESIONS POST TREATMENT OF UNRUPTURED ANEURYSMS. A DISTINCTIVE SEMILUNAR SIGNAL PATTERN, IDENTIFIED USING 3-T MR ANGIOGRAPHY, REPRESENTED FLOW OUTSIDE THE CONFINES OF THE ENTERPRISE STENT STRUT. THIS PATTERN, DESIGNATED AS THE CRESCENT SIGN, WAS CONFIRMED TO CORRESPOND TO INCOMPLETE STENT APPOSITION BY USE OF HIGH-RESOLUTION ANGIOGRAPHIC FLAT-PANEL CT SCANNING REVEALING FLOW INGRESS INTO AND EGRESS OUT OF THE ISOLATED LUMINAL WEDGE. THE INCOMPLETE STENT APPOSITION WAS ALSO ASSOCIATED WITH PERIPROCEDURAL IPSILATERAL HYPERINTENSE LESIONS ON DIFFUSION WEIGHTED IMAGING. THESE RESULTS IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS. THE PATIENT DID NOT SUFFER ANY IRREVERSIBLE CLINICAL DEFICIT ATTRIBUTED TO THE LESIONS NOTED ON DIFFUSION-WEIGHTED IMAGING BY THE TIME OF DISCHARGE. THE CRESCENT SIGN WAS STRONGLY PREDICTIVE OF IPSILATERAL POSTPROCEDURAL LESIONS SEEN ON DIFFUSION-WEIGHTED IMAGING IN THE ENTIRE POPULATION INCOMPLETE STENT APPOSITION IS DETECTABLE ON 3-T MR ANGIOGRAPHY AS A CRESCENT SIGN, AND WAS FOUND TO BE HIGHLY PREVALENT IN ENTERPRISE CLOSED-CELL DESIGN STENTS USED TO ASSIST COIL EMBOLIZATION OF ANEURYSMS. THE RESULTS OF THE STUDY IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1