BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2221393 · Received August 24, 2011

    Report

    Report Number
    1058196-2011-00422
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    December 10, 2010
    Report Date
    July 27, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE (B)(6) STUDY INDICATED THAT APPROXIMATELY EIGHT MONTHS AFTER AN ENTERPRISE VRD ASSISTED COIL EMBOLIZATION PROCEDURE DURING FOLLOW-UP ANGIOGRAPHY A 50% INTRA-STENT/CEREBRAL ARTERY STENOSIS WAS OBSERVED WHICH WAS CONSIDERED TO NOT BE CLINICALLY SIGNIFICANT. THE (COILED) ANEURYSM WAS FOUND TO BE SUCCESSFULLY OCCLUDED. NO RE-INTERVENTION WAS PERFORMED. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT IS TO CONTINUE THE PRESCRIBED MEDICAL REGIMEN (KARDEGIC) AND WILL HAVE ADDITIONAL ANGIOGRAPHIC FOLLOW-UP AT TWO YEARS. THE INDEX PROCEDURE WAS A STENT ASSISTED COIL EMBOLIZATION OF A RIGHT MEDIAL CEREBRAL BIFURCATION ANEURYSM. THE ANEURYSM WAS DE NOVO, SACCULAR, AND NON-RUPTURED. THE ANEURYSM MEASURED: 6.16 MM SAC HEIGHT, 4.1 MM SAC WIDTH, AND 3.78 MM NECK. A JAILED MICROCATHETER TECHNIQUE WAS USED AND TREATMENT WAS ACHIEVED WITH COMPLETE OCCLUSION AND NO ADVERSE EVENTS. MEDICATIONS WERE INDICATED AS HEPARIN INTRA AND POST PROCEDURE, PRE AND POST PROCEDURE ANTIPLATELETS (E.G. CLOPIDOGREL, TICLOPIDINE), AND POST PROCEDURE ASPIRIN. THE STENT REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01419564. 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. STENOSIS OF THE STENTED SEGMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE. UNDERLYING PATIENT AND PROCEDURAL FACTORS MAY PLAY A ROLE; HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING POSSIBLE CONTRIBUTING FACTORS. THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD AN ENTERPRISE VRD AND DELIVERY STENT IMPLANTED DURING THE STUDY INDEX PROCEDURE. THE INDEX PROCEDURE WAS A STENT ASSISTED COIL EMBOLIZATION OF A RIGHT MEDIAL CEREBRAL BIFURCATION ANEURYSM. THE ANEURYSM WAS DE NOVO, SACCULAR, AND NON-RUPTURED. THE ANEURYSM MEASURED: 6.16 MM. SAC HEIGHT, 4.1 MM SAC WIDTH, AND 3.78 MM. NECK. THE PATIENT WAS DISCHARGED THE DAY OF THE PROCEDURE. APPROXIMATELY EIGHT MONTHS AFTER THE INDEX PROCEDURE, DURING FOLLOW-UP ANGIOGRAPHY, THE PATIENT WAS FOUND TO HAVE A 50% INTRA-STENT/CEREBRAL ARTERY STENOSIS AND WAS CONSIDERED TO NOT BE CLINICALLY SIGNIFICANT. THE (COILED) ANEURYSM WAS FOUND TO BE SUCCESSFULLY OCCLUDED. NO RE-INTERVENTION WAS PERFORMED. THE PATIENT WAS ASYMPTOMATIC. THE PATIENT IS TO CONTINUE THE PRESCRIBED MEDICAL REGIMEN AND WILL HAVE ADDITIONAL ANGIOGRAPHIC FOLLOW-UP AT TWO YEARS.

    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 13471861

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening