BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3100470 · Received May 8, 2013

    Report

    Report Number
    1058196-2013-00121
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 24, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN A PUBLISHED ARTICLE WAKHLOO, A.J., ET ALL 'CLOSED-CELL STENT FOR COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS: CLINICAL AND ANGIOGRAPHIC RESULTS' AJNR 33:1651-56, OCT. 2012 EVALUATED THE SAFETY AND EFFICACY OF CLOSED-CELL STENT ASSISTED COIL EMBOLIZATION (SACE). A SINGLE INSTANCE OF PROXIMAL STENT MIGRATION OCCURRED FOLLOWING SACE OF A BASILAR TIP ANEURYSM IN WHICH A 14MM STENT WAS DEPLOYED FROM THE RIGHT P1 SEGMENT OF THE POSTERIOR CEREBRAL ARTERY TO THE BASILAR ARTERY WITHOUT UNTOWARD EVENTS. IT WAS REPORTED THAT THE CAUSE FOR MOVEMENT OF THE DEVICE THAT OCCURRED WITHIN A FEW MINUTES AFTER DEPLOYMENT AND AFTER COIL PLACEMENT WAS SELECTION OF A TOO SHORT DEVICE, I.E. 15MM LONG IMPLANT. THE DISTAL AND PROXIMAL END OF THE DEVICE WAS PROPERLY EMBEDDED IN THE ARTERY. THE DISTAL DIAMETER WAS APPROXIMATELY 2.0MM AND THE PROXIMAL DIAMETER 3.5MM. IT WAS REPORTED THAT THE DEVICE WAS SHORT AND THIS DIDN'T SUFFICIENTLY COVER THE DISTAL PART OF THE ARTERY. THE DEVICE REMAINS IMPLANTED. THE LOT NUMBER IS NOT AVAILABLE; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. STENT MIGRATION IS A KNOWN POTENTIAL EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD IN THE INTRACRANIAL VASCULATURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. AS REPORTED THE SELECTION OF TOO SHORT OF A DEVICE WITH INSUFFICIENT COVERAGE OF THE DISTAL ARTERY CONTRIBUTED TO THE EVENT. THE IFU WARNS TO SELECT A STENT LENGTH THAT IS AT LEAST 10 MM LONGER THAN THE ANEURYSM NECK TO INSURE A MINIMUM OF 5 MM ON EITHER SIDE OF THE ANEURYSM NECK. IT FURTHER WARNS THAT A LARGE DIFFERENTIAL IN DIAMETER BETWEEN THE PROXIMAL AND DISTAL SEGMENTS OF THE PARENT VESSEL MAY INCREASE THE RISK OF STENT MIGRATION. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT WITH CLINICAL FACTORS/VESSEL CHARACTERISTICS AND DEVICE SIZE SELECTION APPEARING TO HAVE CONTRIBUTED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, THE DATE OF EVENT IS UNKNOWN AND WAS THEREFORE ENTERED IN AS (B)(6) 2013. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IN A PUBLISHED ARTICLE WAKHLOO, A.J., ET ALL "CLOSED-CELL STENT FOR COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS: CLINICAL AND ANGIOGRAPHIC RESULTS" AJNR 33:1651-56, OCT. 2012 EVALUATED THE SAFETY AND EFFICACY OF CLOSED-CELL STENT ASSISTED COIL EMBOLIZATION (SACE). A SINGLE INSTANCE OF PROXIMAL STENT MIGRATION OCCURRED FOLLOWING SACE OF A BASILAR TIP ANEURYSM IN WHICH A 14MM STENT WAS DEPLOYED FROM THE RIGHT P1 SEGMENT OF THE POSTERIOR CEREBRAL ARTERY TO THE BASILARY ARTERY WITHOUT UNTOWARD EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201171 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1