BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3183208 · Received June 21, 2013

    Report

    Report Number
    1058196-2013-00171
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 26, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITH VIA LITERATURE SEARCH MALEK ET AL ¿INCOMPLETE STENT APPOSITION IN ENTERPRISE STENT-MEDIATED COILING OF ANEURYSMS: PERSISTENCE OVER TIME AND RISK OF DELAYED ISCHEMIC EVENTS¿ J. NEUROSURG/MARCH 15, WAS NOTED AND REVIEWED. IT IS NOTED THAT IN ADDITION TO THE EVENTS CAPTURED VIA A PREVIOUSLY PUBLISHED ARTICLE (MALEK AT AL MAY 2007 J.NEUROSURG) WITH CONTINUATION OF THE ENROLLMENT THERE WERE REPORTS OF FOUR ADDITIONAL CASES OF INCOMPLETE APPOSITION OF THE ENTERPRISE STENT WITH FOUR IPSILATERAL LESIONS. A 4.5MM * 22 MM ENTERPRISE (ENF452212/LOT M1423533) WAS IMPLANTED IN THE RIGHT ICA (B)(6). THE PATIENT NOTED AN EPISODE OF RIGHT-SIDED VISUAL LOSS WITH OCCASIONAL BILATERAL SCINTILLATING SCOTOMAS OCCURRING APPROXIMATELY 10 MONTHS AFTER STENT PLACEMENT. THE PATIENT WAS ON ASA; CLOPIDOGREL HAD BEEN DISCONTINUED 4 MONTHS PRIOR. THERE WAS NO RECURRENCE OF VISUAL LOSS SINCE THE EPISODE, THOUGH SCINTILLATING SCOTOMAS CONTINUE. THE LATEST MRS SCORE WAS 0. THE FIRST PUBLISHED 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 INITIAL IT WAS STATED THAT THE INITIAL REPORTS ON INCOMPLETE APPOSITION DEMONSTRATED THAT THE CRESCENT SIGN CAN BE LOCATED ON EITHER THE INNER OR OUTER CURVE OF THE STENT CONTAINING ARTERY. VESSELS WITH LARGER DIAMETERS AND MORE TORTUOUS ANATOMY ARE MORE PRONE TO CAUSE CENTRAL CRIMPING AND LOSS OF STENT LUMINAL DIAMETER THAT LEADS TO INCOMPLETE STENT APPOSITION AND THE APPEARANCE OF THE CRESCENT SIGN ON MRA. IT IS REPORTED THAT EVALUATION OF THE CLINICAL IMPLICATION OF THE CRESCENT SIGN REVEALED THAT IT WS SIGNIFICANTLY RELATED TO AN INCREASE RISK OF PROCEDURAL ISCHEMIC LESIONS DETECTED ON DIFFUSION-WEIGHTED 3-T MRI. THE RESULTS OF THE PREVIOUSLY PUBLISHED ARTICLE IN 2007 WAS LIMITED TO PERIPROCEDURAL PERIOD AND HYPOTHESIZED THAT POOR STENT APPOSITION AS SHOWN BY THE CRESCENT SIGN WOULD BE A RISK FACTOR OR DELAYED ISCHEMIC EVENTS OCCURRING AFTER HOSPITAL DISCHARGE OR SEEN ON SUBSEQUENT IMAGING, SYMPTOMATIC OR ASYMPTOMATIC. THE LATEST ARTICLE EVALUATES THAT HYPOTHESIS BY FOLLOWING THE NATURAL HISTORY OF THE COHORT OF PATIENTS WITH ANALYSIS OF THEIR SUBSEQUENT CLINICAL AND RADIOGRAPHIC TIME COURSE. IT WAS SITED THAT RECENT DATA FROM THE ICES REGISTRY DEMONSTRATED A CORRELATION BETWEEN THE TIMING OF CESSATION OF DOUBLE ANTIPLATELET THERAPY AND DELAYED ISCHEMIC EVENTS, HIGHLIGHTING THE IMPORTANCE OF CONTINUING AN ANTIPLATELET REGIMEN IN CERTAIN CASES. THERE WAS NO SIGNIFICANT RELATIONSHIP BETWEEN PERIPROCEDURAL STROKES AND THE PRESENCE OF A CRESCENT SIGN ON POSTOPERATIVE IMAGING, BUT WERE ASSOCIATED WITH DEVELOPMENT OF DELAYED ISCHEMIC EVENT; 86% OF THE PATIENTS TREATED IN THE SERIES REMAINED ASYMPTOMATIC (MRS SCORE 0), 6% HAD AN MRS SCORE OF 1, 6% AN MRS SCORE OF 2, AND 2% AN MRS SCORE OF 4. ALTHOUGH THERE WAS NO SIGNIFICANT ASSOCIATION BETWEEN FINAL CLINICAL OUTCOME AND THE PRESENCE OF A CRESCENT SIGN, PRESENTING WITH SAH WAS A SIGNIFICANT PREDICTOR OF POOR CLINICAL OUTCOME. PERMANENT INFARCTS OCCURRED IN SIGNIFICANTLY MORE PATIENTS WITH A CRESCENT SIGN THAN WITHOUT EXPERIENCED A PERMANENT INFARCT, A FINDING REPRODUCABLE WITH EXCLUSION OF THOSE PRESENTING WITH SAH. DELAYED ISCHEMIC EVENTS OCCURRED IN 36% OF PATIENTS WITH INCOMPLETE STENT APPOSITION WHEREAS THERE WERE NONE IN THOSE WITHOUT INCOMPLETE STENT APPOSITION. BOTH ASYMPTOMATIC INFARCTS AND SYMPTOMATIC INFARCTS WERE INCLUDED IN THE ANALYSIS. WHILE 6 OF 8 PATIENTS WITH DELAYED ISCHEMIC EVENTS WERE SYMPTOMATIC, THERE WAS ONLY A SINGLE PATIENT WITH A PERMANENT NEUROLOGICAL DEFICIT (2%). A TOTAL OF 3 PERMANENT INFARCTS (6%) OCCURRED IN A DELAYED FASHION. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. STENT MALPOSITION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. THROMBOSIS OF THE STENT OR VESSEL AND EMBOLIC EVENTS WITH ASSOCIATED NEUROLOGICAL DEFICITS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE ENTERPRISE VRD IS INTENDED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSMS ARISING FROM A PARENT VESSEL WITH A DIAMETER OF 2.5MM AND 4MM. THE IFU OUTLINES THAT IT IS GENERALLY CONTRAINDICATED IN PATIENTS IN WHOM THE ANGIOGRAPHY DEMONSTRATES ANATOMY IS NOT APPROPRIATE FOR ENDOVASCULAR TREATMENT DUE TO SEVERE INTRACRANIAL VESSEL TORTUOSITY AND IN PATIENTS IN WHOM ANTIPLATELET AND/OR ANTICOAGULATION THERAPY IS CONTRAINDICATED. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL CHARACTERISTICS AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THESE EVENTS WERE ORIGINALLY REPORTED AS ONE SR AND SUBSEQUENTLY OPENED AS SEPARATE THE EVENTS WERE PREVIOUSLY REPORTED UNDER MDR 1058196-2013-00143 AND THAT BASED ON ADDITIONAL INFORMATION RELATING SPECIFIC PRODUCT CODE TO SPECIFIC PATIENTS AND EVENTS THE REPORTS WERE REVISED TO ADDRESS ONE EVENT INVOLVING ONE DEVICE WITH SUBMISSION OF F/U INFORMATION FOR THE OTHER 3 INITIALLY CAPTURED EVENTS VIA SEPARATE REPORTS INCLUDING MFG REPORT # 1058196-2013-00170, 1058196-2013-00171, AND 1058196-2013-00172. THE MDR #S FROM THE FIRST PUBLISHED ARTICLE INCLUDE: 1058196-2011-00337 THRU 00355 & 00358 & 00359.

    Additional Manufacturer Narrative · 1

    LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT M1423533. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. IT SHOULD BE NOTED THAT THE REPORTED LOT HAS A USE BY DATE OF 2011-02, AS INDICATED IN THE DEVICE HISTORY RECORDS.

    Description of Event or Problem · 1

    WITH VIA LITERATURE SEARCH MALEK ET AL ¿INCOMPLETE STENT APPOSITION IN ENTERPRISE STENT-MEDIATED COILING OF ANEURYSMS: PERSISTENCE OVER TIME AND RISK OF DELAYED ISCHEMIC EVENTS¿ J. NEUROSURG/MARCH 15, WAS NOTED AND REVIEWED. IT IS NOTED THAT IN ADDITION TO THE EVENTS CAPTURED VIA A PREVIOUSLY PUBLISHED ARTICLE (MALEK AT AL MAY 2007 J.NEUROSURG) WITH CONTINUATION OF THE ENROLLMENT THERE WERE REPORTS OF FOUR ADDITIONAL CASES OF INCOMPLETE APPOSITION OF THE ENTERPRISE STENT WITH FOUR IPSILATERAL LESIONS. THE EVENT OF TRANSIENT ISCHEMIC ATTACK (TIA) WAS INDICATED. A 4.5MM * 22 MM ENTERPRISE (ENF452212) WAS IMPLANTED IN THE RIGHT ICA. PATIENT NOTED AN EPISODE OF RIGHT-SIDED VISUAL LOSS WITH OCCASIONAL BILATERAL SCINTILLATING SCOTOMAS OCCURRING APPROXIMATELY 10 MONTHS AFTER STENT PLACEMENT. ON ASA; CLOPIDOGREL HAD BEEN DISCONTINUED 4 MONTHS PRIOR. NO RECURRENCE OF VISUAL LOSS SINCE EPISODE, THOUGH SCINTILLATING SCOTOMAS CONTINUE. LATEST MRS SCORE 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283391 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA M1423533

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening