BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2130330 · Received June 16, 2011

    Report

    Report Number
    1058196-2011-00299
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    October 12, 2010
    Report Date
    May 26, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PROWLER SELECT PLUS MICROCATHETER (MC), SHUTTLE SHEATH MICROCATHETER, EXCELSIOR, ECHELON GW, CHIKAI GT WIRE, ORBIT COILS (638CF0721/LOT 16147547 X 4 UNITS), MICRO PLEX, PRESISIO, AND HYDRO COIL. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422126. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), 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. CEREBRAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AND THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT AND PROCEDURAL FACTORS INCLUDING VESSEL DIAMETER, AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT FROM A CLINICAL STUDY (B)(4) FOR PATIENT WITH ID (B)(4) INDICATED THAT THE DAY AFTER THE COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (ENC452212), THE PATIENT DEVELOPED INFARCTION IN RIGHT THE CEREBRAL HEMISPHERE WITH PARALYSIS ON THE LEFT SIDE. RECOVERY FROM THE SYMPTOMS WAS CONFIRMED, AND THE PATIENT WAS DISCHARGED APPROXIMATELY A MONTH AFTER ONSET. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE, AND NO COIL WAS PROTRUDING INTO THE PARENT ARTERY. THE UNRUPTURED SACCULAR ANEURYSM OF THE RIGHT CAVERNOUS SINUS NECK MEASURED 10.4MM AND THE NECK TO SAC RATIO WAS 10.4/22.8MM, AND THE PARENT VESSEL PROXIMAL DIAMETER WAS 5.2MM AND THE DISTAL WAS 3.9MM. MEDICATIONS CONSISTED OF ASPIRIN 100MG/DAY (DATE UNKNOWN) AND PLAVIX 75MG/DAY ((B)(6) 2010). A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE.

    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 01422126

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening