BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2080118 · Received May 6, 2011

    Report

    Report Number
    1058196-2011-00207
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 15, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DAY AFTER THE CEREBRAL INFARCTION, THE PATIENT HAD DIPLOPIA AND ORIENTATION DISTURBANCE. AS PREVIOUSLY CAPTURED THE PATIENT WAS TREATED MEDICALLY, AND THE EVENT IS ONGOING. NO FURTHER INFORMATION WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE SACCULAR ANEURYSM WAS UNRUPTURED AND MEASURE AT THE NECK WAS 13.7MM AND THE NECK TO SAC RATIO WAS 13.7MM/16.7MM. THE PARENT VESSEL DIAMETER PROXIMALLY WAS 3.8MM AND DISTALLY WAS 3.2MM. MEDICATIONS CONSISTED OF ASPIRIN 100MG/DAY (DATE UNKNOWN) AND PLAVIX 75MG/DAY ((B)(6) 2011). A CD COPY OF THE PROCEDURE WAS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. PRODUCTS USED DURING THE CASE CONSISTED OF PROWLER SELECT PLUS (FOR ENTERPRISE DELIVERY ), ROAD MASTER 7FRENCH GUIDING CATHETER, EXCELSIOR, CHIKAI GUIDEWIRE, TRAXCESS, ORBIT COIL, MICROPLEX COIL, HYDRO COIL, DELTA PAQ COIL, AND DELTA PLUSH COIL. THE STENT REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425453. 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. BASED ON THE AVAILABLE INFORMATION AND WITHOUT PROCEDURAL/DIAGNOSTIC IMAGES, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE EVENT AND THE ENTERPRISE VRD. PATIENT FACTORS INCLUDING PRE-EXISTING MEDICAL CONDITION WITH MRS 3, 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 REPORT FROM A CLINICAL STUDY (B)(4) FOR PATIENT WITH ID (B)(4) INDICATED THAT AFTER A COIL EMBOLIZATION PROCEDURE OF THE CENTRAL (BA) BASILAR ARTERY-TIP ASSISTED WITH AN ENTERPRISE VRD (ENC452812), THE PATIENT DEVELOPED INFARCTION OF LEFT OPTIC THALAMUS THAT WAS TREATED WITH DRUG THERAPY (SLONNON, RADICUT, INOVAN), AND RESOLUTION WAS NOTED THAT IT IS ONGOING. ADDITIONALLY, SEVERE BLEEDING WAS OBSERVED FROM THE PUNCTURE SITE THE DAY AFTER THE PROCEDURE. ANGIOGRAPHY AND MANUAL HEMOSTASIS WERE DONE, AND RECOVERY WAS CONFIRMED APPROXIMATELY A MONTH AFTER THE ONSET. NO DISSECTIONS WERE NOTED DURING THE PROCEDURE. 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.

    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 01425453

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R