BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2243339 · Received September 12, 2011

    Report

    Report Number
    1058196-2011-00436
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    April 29, 2011
    Report Date
    August 31, 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

    DEVICES UTILIZED CONSISTED OF ROADMASTER GUIDE CATHETER (GOODMAN), CERULEAN G50 (MEDIKIT), PROWLER SELECT PLUS MICROCATHETER (606-S255FX/15127858), SILVERSPEED 14 GUIDEWIRE (EV3), ECHELON 14 MICROCATHETER (EV3), GDC 360 COIL (BOSTON SCIENTIFIC), ORBIT COMPLEX FILL COIL (637CF0721/15124036), ORBIT COMPLEX FILL COIL (637CF0615/15129001), ORBIT COMPLEX FILL COIL (637CF0515/15195839), GDC 10 ULTRASOFT COIL X7 (BOSTON SCIENTIFIC), GDC 10 SOFT SR COIL X2 (BOSTON SCIENTIFIC), GDC 18 SOFT COIL (BOSTON SCIENTIFIC), ORBIT GALAXY COMPLEX XTRASOFT COIL X2 (640HX0208/13500275), ORBIT GALAXY COMPLEX XTRASOFT COIL (640HX0206/14086893), ORBIT GALAXY COMPLEX XTRASOFT COIL (640HX0206/13500186), HYPERFORM BALLOON (EV3), AND TRUFILL DCS SYRINGE II (635-002/96331103). THE ANTIPLATELET THERAPY CONSISTED OF ASPIRIN 100MG/DAY: (B)(6) 2011, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2011, AND HEPARIN 3500U: (B)(6) 2011 (DURING THE PROCEDURE). THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 5.9MM, AND THE NECK TO SAC RATION WAS 5.9/10.5MM, AND THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.9MM AND DISTALLY WAS 3.8MM. A CD COPY OF THE PROCEDURE WAS NOT AVAILABLE, AND NO FURTHER INFORMATION WAS PROVIDED. THE PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED VIA THE (B)(4) CLINICAL THAT ONE DAY POST ENTERPRISE VRD ASSISTED COIL EMBOLIZATION OF A LEFT POSTERIOR COMMUNICATING (PCOM) ARTERY ANEURYSM, THE PATIENT DEVELOPED RIGHT HEMIPLEGIA AND APHASIA WITH CT AND MRI REVEALING ISCHEMIA OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). DURING THE EVENT ANGIOGRAPHY WAS CONDUCTED AND NO THROMBUS WAS NOTED AT THE SITE, AND THE STENT WAS PATENT. THE ENTERPRISE STENT WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION. ASPIRIN, CLOPIDOGREL SULFATE, OZAGREL SODIUM, AND EDARAVONE WERE ADMINISTRATED. THE EVENT OUTCOME WAS REPORTED AS ONGOING, IMPROVED ONE MONTH LATER. IT WAS INDICATED THAT NO PRODUCT MALFUNCTIONS WERE REPORTED, AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENTS WAS UNKNOWN. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 5.9MM, AND THE NECK TO SAC RATION WAS 5.9/10.5MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.9MM AND DISTALLY WAS 3.8MM. A TOTAL OF 18 COILS WERE PLACED ADDITIONALLY A HYPERFORM BALLOON WAS USED DURING THE PROCEDURE. THE MODIFIED RANKIN SCALE SCORE BEFORE THE PROCEDURE WAS 2, THREE DAYS POST PROCEDURE, THE SCORE WAS 4, AND ONE MONTH AFTER THE PROCEDURE, THE SCORE WAS 3. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY AND CLOPIDOGREL 75MG/DAY STARTING ONE DAY PRIOR TO THE PROCEDURE. AS SITED IN THE INSTRUCTIONS FOR USE, THE CLINICAL STUDY RECOMMENDED ANTIPLATELET THERAPY STARTING 72 HOURS PRE-PROCEDURE IN ELECTIVE CASES. HEPARIN 3500 UNITS WAS ADMINISTERED INTRA-PROCEDURALLY. THE ACT WAS 112 SECONDS PRE ANTICOAGULATION AND 281 SECONDS POST ANTICOAGULATION. PRIOR OR DURING THE PROCEDURE, NO THROMBUS WAS NOTED AT THE SITE, AND AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, NO THROMBUS OR OTHER ISSUES WERE NOTED AT THE SITE. THE OCCLUSION RATE OF ANEURYSMS WAS 95% AFTER THE PROCEDURE, AND NO COIL WAS PROTRUDING FROM THE ANEURYSM. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THE ENTERPRISE VRD REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424845. 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 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. NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE EVENTS AND THE DEVICE OR PROCEDURE. THE PATIENT'S MEDICAL CONDITION INCLUDING PRE-EXISTING NEUROLOGICAL SYMPTOMS AS EVIDENCED BY THE BASELINE STROKE SCORE, PHARMACOLOGICAL FACTORS, VESSEL/ANEURYSM CHARACTERISTICS, AND PROCEDURAL FACTORS INCLUDING USE OF BALLOON MAY HAVE CONTRIBUTED. WITH REVIEW OF THE REPORTED 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.

    Description of Event or Problem · 1

    THE REPORT POST MARKET CLINICAL STUDY (B)(4) FOR PATIENT WITH ID (B)(4) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION OF AN ANEURYSM IN THE LEFT POSTERIOR COMMUNICATING ARTERY ASSISTED WITH AN ENTERPRISE VRD (ENC452212/ 01424845, AND THE DAY AFTER THE PROCEDURE, THE PATIENT DEVELOPED BOTH RIGHT HEMIPLEGIA AND APHASIA. BOTH CT AND MRI WERE CONDUCTED AND THE ISCHEMIA OF THE RIGHT MIDDLE CEREBRAL ARTERY WAS REVEALED. ASPIRIN, CLOPIDOGREL SULFATE, OZAGREL SODIUM, AND EDARAVONE WERE ADMINISTRATED. THE EVENT OUTCOME A MONTH AFTER ONSET WAS ONGOING AND IMPROVED. NO PRODUCT MALFUNCTIONS WAS REPORTED, AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENTS WAS UNKNOWN. DURING THE EVENT ANGIOGRAPHY WAS CONDUCTED AND NO THROMBUS WAS NOTED AT THE SITE, AND THE STENT WAS PATENT. THE ENTERPRISE WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION. PRIOR OR DURING THE PROCEDURE, NO THROMBUS WAS NOTED AT THE SITE, AND AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, NO THROMBUS OR OTHER ISSUES WERE NOTED AT THE SITE. AFTER THE INITIAL PLACEMENT, THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL. THE OCCLUSION RATE OF ANEURYSMS WAS 95% AFTER THE PROCEDURE, AND NO COIL WAS PROTRUDING FROM THE ANEURYSM.

    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 01424845

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention