BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2069528 · Received April 26, 2011

    Report

    Report Number
    1058196-2011-00179
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    February 18, 2011
    Report Date
    April 1, 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

    OTHER DEVICES UTILIZED CONSISTED OF PROWLER SELECT PLUS, TRAXCESS 14 GUIDEWIRE, TRANSEND EX, X-CELERATOR 14, LAUNCHER 7FRENCH GUIDING CATHETER, SL10 MICROCATHETER, EXCELSIOR 1018, ORBIT COILS (QTY 49), AND GDC COILS (QTY 6). LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424663. 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. ISCHEMIA AND NEUROLOGICAL DEFICITS ARE KNOWN POTENTIAL ADVERSE EVENTS 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, PROCEDURAL 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 CLINICAL STUDY (B)(4) STUDY FOR PATIENT WITH ID (B)(4), INDICTED THAT THE PATIENT HAD TRANSIENT ISCHEMIC ATTACK WAS DEVELOPED 8 HOURS AFTER THE UNDERGOING ENTERPRISE PLACEMENT. TRANSIENT MUSCLE WEAKNESS OF RIGHT UPPER / LOWER LIMB WAS OBSERVED. OBVIOUS FINDING OF INFARCTION WAS NOT SEEN BY MRI. DRUG THERAPY WAS DONE WITH NOVASTAN 20MG/DAY AND RADICUT 60MG/DAY. THE PATIENT RECOVERED ON (B)(6) 2011. THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH THE VRD STENT (ENC453712) FOR UNRUPTURED ANEURYSM IN SELLAR. THE MODIFIED RANKIN SCALE PRE-PROCEDURE WAS 0, AFTER (WITHIN A WEEK) WAS 0, AND 30 DAYS AFTER WAS 0. MEDICATION CONSISTED OF BAYASPIRIN 100G/DAY ((B)(6) 2007-CONTINUOUSLY) AND PLAVIX 75MG/DAY (B)(6) 2011). 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. THE ANEURYSM WAS SACCULAR AND THE NECK MEASURE 8.7MM, NECK TO SAC RATION WAS 8.7MM/18.6MM. THE PARENT VESSEL DIAMETER PROXIMALLY WAS 3.4MM AND DISTALLY WAS 2.85MM. THERE WERE NO CONDITIONS CAUSING HYPERCOAGULABLE STATE. A CD COPY OF THE PROCEDURE WAS 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 01424663

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention