BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2190106 · Received August 4, 2011

    Report

    Report Number
    1058196-2011-00396
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 22, 2011
    Report Date
    July 21, 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

    IT WAS REPORTED VIA THE (B)(4) STUDY THAT THE PATIENT DEVELOPED AN ASYMPTOMATIC CEREBRAL INFARCTION ONE DAY POST STENT ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED RIGHT PARASELLAR ANEURYSM. THE INFARCTION WAS IN THE RIGHT CAPUT NUCLEI CAUDATE WITH NO TREATMENT PROVIDED. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED FOUR DAYS POST PROCEDURE. IT WAS REPORTED THAT THE RELATIONSHIP TO THE EVENT AND THE ENTERPRISE VRD IS UNKNOWN. NO THROMBUS WAS NOTED AT THE SITE PRIOR TO OR DURING THE PROCEDURE AND NO THROMBUS OR ANY OTHER ISSUES WERE NOTED WHEN THE PROCEDURE WAS COMPLETED. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL PLACEMENT AND WAS IN A STABLE POSITION AFTER PLACEMENT WITH VESSEL WALL APPOSITION. A TOTAL OF THREE COILS WERE PLACED. RAYMOND CLASSIFICATION VALUE BEFORE AND AFTER THE PROCEDURE WERE 3 (ANEURYSM OBLITERATED LESS <95%). AT BASELINE, THE SACCULAR ANEURYSM HAD A NECK OF 7.0MM WITH A NECK TO SAC RATIO OF 7.0MM/4.1MM. THE PROXIMAL PARENT VESSEL WAS 3.6MM WITH A DISTAL VESSEL DIAMETER OF 3.4MM. ANTIPLATELET THERAPY INCLUDED CILOSTAZOL 100MG/DAY FOR ONE WEEK BEGINNING TWO WEEKS PRIOR TO THE PROCEDURE FOLLOWED BY ASPIRIN 100MG/DAY AND CILOSTAZOL 200MG/DAY BEGINNING ONE WEEK PRIOR TO THE PROCEDURE. HEPARIN 8000 UNITS WAS ADMINISTERED FROM THE PROCEDURE DAY TO ONE DAY POST FOLLOWED BY HEPARIN 6000 UNITS ONE DAY POST THROUGH TWO DAYS POST PROCEDURE. THE MODIFIED RANKIN SCALE SCORE WAS 0 PRE-PROCEDURE AS WELL AS ONE DAY POST PROCEDURE. NO PROCEDURAL/DIAGNOSTIC IMAGES ARE AVAILABLE. THE STENT REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01426711. 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 ENTERPRISE VRD AND THE PROCEDURES THEY ARE USED IN AS OUTLINED IN THE INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFORMATION AND AS REPORTED, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE REPORTED EVENT AND THE DEVICE. WITH REVIEW OF THE AVAILABLE INFORMATION AND THE DEVICE HISTORY RECORDS 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.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE INITIAL MEDWATCH SUBMITTED ON (B)(4) 2011 WITH THE ALERT DATE OF (B)(4) 2011 WAS MISSING SOME INFORMATION. PLEASE SEE BELOW FOR ENTIRE ACQUIRE INFORMATION: THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT WITH ID #(B)(4) THE PATIENT DEVELOPED ASYMPTOMATIC CEREBRAL INFARCTION IN RIGHT CAPUT NUCLEI CAUDATI AFTER UNDERGOING ASSISTED COIL EMBOLIZATION WITH AN ENTERPRISE VRD (B)(4) FOR CEREBRAL ARTERY ANEURYSM IN RIGHT PARASELLAR. NO TREATMENT WAS PROVIDED, AND THE EVENT RESOLVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THREE DAYS AFTER ONSET. THE PHYSICIAN COMMENTED THAT THE RELATIONSHIP OF THE EVENT TO THE ENTERPRISE AND TO THE PROCEDURE WAS UNKNOWN. THE MODIFIED RANKIN SCALE BEFORE THE PROCEDURE WAS 0 AND 1 DAY AFTER THE PROCEDURE WAS 0. THE ACT WAS NOT MEASURED. PRIOR OR DURING THE PROCEDURE, NO THROMBUS WAS NOTED AT THE SITE OR THE STENT IMPLANTED WITHIN THE THROMBUS. AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, NO THROMBUS OR OTHER ISSUES WERE NOTED AT THE SITE, AND THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL AND POST PROCEDURE PLACEMENT. THE RESIDUAL FLOW INTO THE ANEURYSM WAS RAYMOND CLASSIFICATION VALUE BEFORE AND AFTER THE PROCEDURE WAS 3 (ANEURYSM OBLITERATED LESS <95%). PRODUCTS UTILIZED DURING THE PROCEDURE CONSISTED OF A ROADMASTER GUIDING CATHETER (TH/ GOODMAN), PROWLER SELECT PLUS MICROCATHETER ((B)(4)/LOT# UNKNOWN), FAST TRACKER 10 MICROCATHETER (BOSTON SCIENTIFIC), RADIFOCUS GUIDEWIRE (GT GW/ TERUMO QUICK FLEX/ KANEKA), ORBIT GALAXY COMPLEX XTRASOFT COIL ((B)(4)/LOT# UNKNOWN) AND DELTAPLUSH 10 COILS (MICRUS X2. THE ANTIPLATELET THERAPY CONSISTED OF ASPIRIN 100MG/DAY: 2011-(B)(6) ~, CILOSTAZOL 200MG/DAY: 2011-(B)(6) ~, CILOSTAZOL 100MG/DAY: 2011-(B)(6), HEPARIN 8000U: 2011-(B)(6), AND HEPARIN 6000U: 2011-(B)(6). THE UNRUPTURED SACCULAR ANEURYSM MEASURED NECK 7.0MM AND THE NECK TO SAC RATIO WAS 7.0MM/4.1MM, AND THE PARENT VESSEL SIZE/DIAMETER PROXIMALLY WAS 3.6MM AND DISTALLY WAS 3.4MM. A CD COPY OF THE PROCEDURE OR FURTHER INFORMATION WAS NOT AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT WITH ID (B)(4); THE PATIENT DEVELOPED ASYMPTOMATIC CEREBRAL INFARCTION IN RIGHT CAPUT NUCLEI CAUDATI AFTER UNDERGOING ASSISTED COIL EMBOLIZATION WITH AN ENTERPRISE VRD (ENC452812) FOR CEREBRAL ARTERY ANEURYSM IN RIGHT PARASELLAR. NO TREATMENT WAS PROVIDED, AND THE EVENT RESOLVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THREE DAYS AFTER ONSET. THE PHYSICIAN COMMENTED THAT THE RELATIONSHIP OF THE EVENT TO THE ENTERPRISE AND TO THE PROCEDURE WAS UNKNOWN. PRIOR OR DURING THE PROCEDURE, NO THROMBUS WAS NOTED AT THE SITE OR THE STENT IMPLANTED WITHIN THE THROMBUS. AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, NO THROMBUS OR OTHER ISSUES WERE NOTED AT THE SITE, AND THE ENTERPRISE WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AFTER INITIAL AND POST PROCEDURE PLACEMENT. THE RESIDUAL FLOW INTO THE ANEURYSM WAS RAYMOND CLASSIFICATION VALUE BEFORE AND AFTER THE PROCEDURE WAS 3 (ANEURYSM OBLITERATED LESS <95%).

    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 01426711

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening SEE SECTION H 10