BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2073155 · Received April 29, 2011

    Report

    Report Number
    1058196-2011-00187
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING A STENT ASSISTED COILING PROCEDURE OF THE BASILAR ARTERY TIP BIFURCATION ANEURYSM THERE WAS INACCURATE PLACEMENT OF THE ENTERPRISE VRD DUE TO SUDDEN RELEASE OF THE TENSION ON THE MICROCATHETER WHICH STRAIGHTENED IT. THIS RESULTED IN THE NECK NOT BEING COVERED AND ENTRAPMENT OF THE PROXIMAL PART OF THE ORBIT COIL (638CF1230) WHICH HAD BEEN PARTIALLY DEPLOYED IN THE ANEURYSM USING A JAILED MICROCATHETER. THE REMAINING PART OF THE COIL WAS PUT INSIDE OF THE ANEURYSM AND AN ADDITIONAL ENTERPRISE STENT WAS PLACED. ADDITIONALLY, DURING THE PROCEDURE ANOTHER ORBIT COIL STRETCHED DURING INSERTION THROUGH AN SL10 MICROCATHETER. THE STRETCHED COIL WAS REMOVED AS A UNIT WITH THE MICROCATHETER. THE PARENT VESSEL SIZE WAS 3.8MM PROXIMAL TO THE NECK AND 2.9MM DISTALLY. THE NECK WAS 4.3MM, 3.8 DOME, 3.7 DEPTH AND 4.2 HEIGHT. AFTER DEPLOYING HALF OF THE ORBIT COIL (638CF1230), THE ENTERPRISE VRD WAS DEPLOYED. HOWEVER, THE ENTERPRISE "JUMPED" TO THE DISTAL AREA OF THE PARENT VESSEL DUE TO THE TENSION ON THE PROWLER SELECT PLUS 45 MICROCATHETER WAS SUDDENLY RELEASED AND IT WAS STRAIGHTENED. A PROVIDED DRAWING OF THE EVENT SHOWED THAT THE ENTERPRISE STENT WAS JUST DISTAL TO THE NECK OF THE BASILAR TIP ANEURYSM IN THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA). THE DISTAL PART OF THE COIL WAS WITHIN THE ANEURYSM AND THE PROXIMAL PART OF THE ORBIT COIL (638CF1230) WAS JAMMED BETWEEN THE ENTERPRISE VRD AND PARENT VESSEL. A SECOND ENTERPRISE WAS PLACED IN THE BASILAR ARTERY EXTENDING INTO THE LEFT PCA. DURING THE PROCEDURE, THE ENTERPRISE STENT WAS NOT RE-CAPTURED. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. DURING DELIVERY AND PLACEMENT, CONSTANT FLUOROSCOPY WAS PERFORMED AT ALL TIMES. THE DISTAL TIP OF THE MICROCATHETER WAS NOT RE-SHAPED. THERE WERE NO DAMAGES NOTED ON THE DISTAL TIP OF THE ENTERPRISE DELIVERY WIRE AND NO DAMAGES ON THE STENT. THERE WERE NO KINKS OR BENDS IN THE SL10 MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE STRETCHING OF THE 2.5X4.5 ORBIT COIL. NO ADDITIONAL TORQUE OR FORCE WAS UTILIZED IN AN ATTEMPT TO ADVANCE THE COIL SYSTEM THROUGH THE MICROCATHETER, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER. THE INNER DIAMETER OF THE MICROCATHETER IS 0.0165. OTHER THAN THE STRETCHED COIL, THERE WERE NO OTHER DAMAGES NOTED ON THE DELIVERY SYSTEM. PROCEDURAL IMAGES ARE NOT AVAILABLE. THE ENTERPRISE STENT REMAINS IMPLANTED AND THE DELIVERY SYSTEM IS NOT AVAILABLE FOR ANALYSIS. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422400. 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. THIS PACKAGING LOT CONTAINED 50 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON MAY 6, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE INSTRUCTIONS FOR USE OUTLINES TO AFTER ADVANCING AND POSITIONING THE STENT AT THE TARGET SITE WITHIN THE MICROCATHETER IF STENT POSITIONING IS SATISFACTORY, CAREFULLY RETRACT THE INFUSION CATHETER, WHILE MAINTAINING THE POSITION OF THE DELIVERY WIRE, TO ALLOW THE STENT TO DEPLOY ACROSS THE NECK OF THE ANEURYSM. BASED ON THE AVAILABLE INFORMATION IT APPEARS THAT VESSEL CHARACTERISTICS AND DEVICE HANDLING DURING THE DEPLOYMENT PROCESS CONTRIBUTED TO THE MOVEMENT OF THE PROWLER SELECT PLUS AND INACCURATE PLACEMENT OF THE ENTERPRISE STENT WITH ENTRAPMENT OF THE ORBIT COIL WHICH WAS INTENTIONALLY ONLY PARTIALLY PLACED IN THE ANEURYSM. THERE IS NO INDICATION OF ANY DEVICE DESIGN OR MANUFACTURING ISSUES RELATED TO THE EVENTS; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00187, 1058196-2011-00188, AND 1058196-2011-00189.

    Additional Manufacturer Narrative · 1

    PRODUCTS UTILIZED DURING THE CASE CONSISTED OF AN ENVOY 45, SL10 90, TRAXCESS M/W AND PROWLER SELECT PLUS 45. THE INNER DIAMETER OF THE MICROCATHETER IS 0.0165. DURING THE PROCEDURE, THE ENTERPRISE STENT WAS NOT RE-CAPTURED. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. DURING DELIVERY AND PLACEMENT, CONSTANT FLUOROSCOPY WAS PERFORMED AT ALL TIMES. THE DISTAL TIP OF THE MICROCATHETER WAS NOT RE-SHAPED. A CD OF THE PROCEDURE WAS NOT AVAILABLE. OTHER THAN THE REPORTED EVENTS, NO OTHER DAMAGES WERE NOTICED ON THE DISTAL TIP (UNRAVELED, STRETCHED, FRACTURE, SEPARATED, KINK, BEND, ETC), STENT (STRUT UPLIFT, KINK, BEND, FRACTURE SEPARATED, ETC), DELIVERY SYSTEM, COIL DELIVERY SYSTEM, OR COIL THAT STRETCHED. THE PARENT VESSEL SIZE WAS 3.8 PROXIMAL 2.9 DISTAL. IT WAS AN ANEURYSM WITH 4.3MM NECK, 3.8 DOME, 3.7 DEPTH AND 4.2 HEIGHT. MEDICATIONS CONSISTED OF ASPIRIN 150 MG AND PLAVIX 75MG FOR 6 DAYS BEFORE THE CASE, 1000 UNITS OF HEPARIN PER AN HOUR DURING 5 HOURS OF THE CASE, AND 150 MG OF ASPIRIN AND 75 MG OF PLAVIX FOR 6 MONTHS AFTER THE CASE. OTHER PROCEDURES GOING TO BE PERFORMED WILL BE PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE. LAKE REGION LOT NUMBER 01422400 IS CORDIS LOT NUMBER 01422400. PER LAKE REGION REPORT (B)(4) LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422400. 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. THIS PACKAGING LOT CONTAINED 50 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON MAY 6, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 8196-2011-00187, 1058196-2011-00188, AND 1058196-2011-00189.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE OF THE BASILAR ARTERY TIP BIFURCATION ANEURYSM, A JAILING TECHNIQUE WAS UTILIZED WITH THE PROCEDURE, AND AFTER DEPLOYING HALF PART OF THE ORBIT COIL (638CF1230), THE ENTERPRISE VRD WAS DEPLOYED. HOWEVER, A DRAWING OF THE EVENT SHOWED THAT THE ENTERPRISE JUMPED TO THE DISTAL AREA OF THE PARENT VESSEL DUE TO THE TENSION ON THE MC WAS SUDDENLY RELEASED AND IT WAS STRAIGHTENED, AND THE NECK AREA WAS NOT COVERED. ADDITIONALLY, THE DISTAL PART OF THE COIL WAS WITHIN THE ANEURYSM AND THE PROXIMAL PART OF THE COIL WAS JAMMED BETWEEN THE ENTERPRISE VRD AND PARENT VESSEL. A SECOND ENTERPRISE WAS PLACED BETWEEN THE VERTEBRAL ARTERY AND PCA TO COVER THE ANEURYSM NECK. ADDITIONALLY, THE ORBIT MINI COMPLEX FILL2.5X4.5 COIL THAT STRETCHED OCCURRED DURING INSERTION THROUGH THE MICROCATHETER, AND BOTH, THE MICROCATHETER (SL 10) AND COIL WERE REMOVED AS UNIT. NO KINKS OR BENDS WERE NOTED ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING THE EVENT, NO ADDITIONAL TORQUE OR FORCE WAS UTILIZED IN AN ATTEMPT TO ADVANCE THE COIL SYSTEM THROUGH THE MICROCATHETER, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER.

    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 01422400

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention