BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    MDR report key: 2073157 · Received April 29, 2011

    Report

    Report Number
    1058196-2011-00189
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    HCG
    PMA / PMN Number
    K053197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT 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. PRODUCTS UTILIZED DURING THE CASE CONSISTED OF AN ENVOY 45, SL10 90, TRAXCESS M/W AND PROWLER SELECT PLUS 45. 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. 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.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15243211 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE DHR REVIEW INDICATES THAT THE PRODUCT WAS TESTED AND INSPECTED PER ESTABLISHED MANUFACTURING REQUIREMENTS INCLUDING INSPECTION RESULTS. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 8196-2011-00187, 1058196-2011-00188, AND 1058196-2011-00189. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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 ((B)(4)) 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 ((B)(4)), 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 ((B)(4)) 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. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15243211 NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4) UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMED THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. THE NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. THE ORBIT COIL THAT WAS REPORTED AS STRETCHED DURING ADVANCEMENT THROUGH THE SL-10 MICROCATHETER IS NOT AVAILABLE FOR ANALYSIS. IT IS POSSIBLE THAT INTERACTION WITH THE CONCOMITANT MICROCATHETER CONTRIBUTED TO THE EVENT; HOWEVER, NO CONCLUSION CAN BE MADE BASED ON THE AVAILABLE INFORMATION. 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 MFG REPORT 1058196-2011-00187, 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 FILL 2.5X4.5 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 TRUFILL DCS ORBIT MINI COMPLEX FILL CNV DCS ORBIT (HCG) HCG CORDIS NEUROVASCULAR, INC. NA 15243211

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention