BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2080029 · Received May 6, 2011

    Report

    Report Number
    1058196-2011-00205
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 13, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE ENTERPRISE VRD AND DELIVERY WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS NOT RETURNED FOR THE ANALYSIS. THE DELIVERY WIRE WAS WITH THE INTRODUCER TUBE INSERTED IN THE DISTAL SECTION. NO VISUAL ANOMALIES WERE FOUND. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE THE STENT WAS NOT RETURNED AND IT IS NECESSARY THAT THE STENT IS STILL INSIDE THE INTRODUCER TUBE TO PERFORM THE FUNCTIONAL ANALYSIS. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425624. 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 325 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON SEPTEMBER 3, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE STENT INADEQUATE RADIOPACITY-MARKERS REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE THE STENT WAS NOT RETURNED FOR ANALYSIS. THE FAILURE STENT DEPLOYMENT DIFFICULTY-INACCURATE PLACEMENT REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE THE STENT WAS NOT RETURNED FOR ANALYSIS; HOWEVER IT DOES NOT APPEARS TO BE MANUFACTURING RELATED OF THE PRODUCT. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE ENTERPRISE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00205 AND 1058196-2011-00206. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE SURGEON FOLLOWED THE INSTRUCTIONS FOR USE STRICTLY (PINCHED THE PROTECTION SHEATH WHEN TAKING THE STENT OUT), AND RECALLS THAT THERE WAS A STENT ABOVE THE DELIVERING CATHETER VAGUELY, BUT DID NOT PAY ATTENTION TO IT WHEN HE PUT IT INTO THE VESSEL. THE DOCTOR COULD NOT SEE THE MARKS WHEN THE STENT WAS POSITIONED AND WANTED TO RELEASE IT. HOWEVER, HE ALSO WITHDREW THE PROWLER PLUS, AND RELEASED THE STENT, AND IMPLANTED 638MF0407, ONLY TO FIND THERE WAS NO STENT SUPPORTING THE NECK. THE DIAMETER OF THE VESSEL WITH THE ANEURYSM IS 3.7MM. THE DSA MACHINE USED DURING THE PROCEDURE WAS A GE INOVA 3100 AN ADVANCED MACHINE THAT SOMETIMES CAN DISPLAY MESH OF ENTERPRISE STENT. AFTER THE EVENTS, WITH FOLLOW-UP ANGIOGRAM, RESIDUAL FLOW WAS NOTED IN THE ANEURYSM. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE, BUT PICTURES OF IMAGES ON A SCREEN WERE PROVIDED. LR PACKAGING L/N# 01423885, 70710523. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01423885. THIS PACKAGING LOT CONTAINED 55 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON AUGUST 31, 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 TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00205 AND 1058196-2011-00206. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN ANEURYSM COIL EMBOLIZATION THE ENTERPRISE STENT HAD INACCURATE DEPLOYMENT AND HAD INADEQUATE RADIOPACITY AND THAT POST PROCEDURE THE PATIENT SUFFERED A CEREBRAL INFARCTION. THIS IS A (B)(6) FEMALE PATIENT WITH UNKNOWN MEDICAL HISTORY. THE DIAMETER OF THE VESSEL WITH THE ANEURYSM IS 3.7MM. DURING A COIL EMBOLIZATION PROCEDURE ASSISTED WITH ENTERPRISE STENT, THE ENTERPRISE 4.5X22 STENT WAS IMPLANTED AFTER PROWLER SELECT PLUS WAS POSITIONED. THE DELIVERING PROCESS WAS SUCCESSFUL, BUT THE DISTAL AND PROXIMAL MARKS COULD NOT BEEN SEEN WHEN THE STENT WAS RELEASED. THE MICRO GUIDE CATHETER WAS REMOVED AND TRUFILL COIL (638MF0407) WAS DETACHED USING THE MICROCATHETER, ONLY TO FIND THERE WAS NO STENT SUPPORTING THE NECK. THE STENT COULD NOT BE LOCATED ON DSA TEST OR IN CT TEST. THE DECISION WAS MADE TO IMPLANT ANOTHER ENTERPRISE (ENC452812) STENT WITH MARKERS COULD BE SEEN CLEARLY. FOUR ORBIT COILS (637MF0304, 637HF0206, 637HF0204, AND 637HF0204) WERE IMPLANTED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT SUFFERED SEVERE INFARCTION OF THE BRAIN AFTER THE PROCEDURE. THE SURGEON FOLLOWED THE INSTRUCTIONS FOR USE STRICTLY (PINCHED THE PROTECTION SHEATH WHEN TAKING THE STENT OUT), AND RECALLS THAT THERE WAS A STENT ABOVE THE DELIVERING CATHETER VAGUELY, BUT DID NOT PAY ATTENTION TO IT WHEN HE PUT IT INTO THE VESSEL. THE DOCTOR COULD NOT SEE THE MARKS WHEN THE STENT WAS POSITIONED AND WANTED TO RELEASE IT. HOWEVER, HE ALSO WITHDREW THE PROWLER PLUS, AND RELEASED THE STENT, AND IMPLANTED 638MF0407, ONLY TO FIND THERE WAS NO STENT SUPPORTING THE NECK. THE DSA MACHINE USED DURING THE PROCEDURE WAS A GE INOVA 3100 AN ADVANCED MACHINE THAT SOMETIMES CAN DISPLAY MESH OF ENTERPRISE STENT. AFTER THE EVENTS, WITH FOLLOW-UP ANGIOGRAM, RESIDUAL FLOW WAS NOTED IN THE ANEURYSM. ONE NON STERILE ENTERPRISE VRD AND DELIVERY WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS NOT RETURNED FOR THE ANALYSIS. THE DELIVERY WIRE WAS WITH THE INTRODUCER TUBE INSERTED IN THE DISTAL SECTION. NO VISUAL ANOMALIES WERE FOUND. THE FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE STENT WAS NOT RETURNED AND ACCORDING TO (B)(4) IS NECESSARY THAT THE STENT IS STILL INSIDE THE INTRODUCER TUBE TO PERFORM THE FUNCTIONAL ANALYSIS. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425624. 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 325 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON SEPTEMBER 3, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE FAILURE STENT INADEQUATE RADIOPACITY-MARKERS REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE THE STENT WAS NOT RETURNED FOR ANALYSIS. THE FAILURE STENT DEPLOYMENT DIFFICULTY-INACCURATE PLACEMENT REPORTED BY THE CUSTOMER WAS NOT CONFIRMED SINCE THE STENT WAS NOT RETURNED FOR ANALYSIS; HOWEVER IT DOES NOT APPEARS TO BE MANUFACTURING RELATED OF THE PRODUCT. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE ENTERPRISE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE FAILURES OF STENT INADEQUATE RADIOPACITY-MARKERS AND STENT DEPLOYMENT DIFFICULTY-INACCURATE PLACEMENT REPORTED BY THE CUSTOMER WERE NOT CONFIRMED SINCE THE STENT WAS NOT RETURNED FOR ANALYSIS. THE DELIVERY DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURES COULD BE RELATED TO THE ENTERPRISE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. CEREBRAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH NEUROVASCULAR STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF CEREBRAL STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL INTO THE DOWNSTREAM FLOW OR VESSEL SPASM IN REACTION TO THE INTRODUCTION OF THE DEVICES THAT MAY SLOW OR COMPLETELY OCCLUDE THE BLOOD FLOW. THE INTRODUCTION OF INTERVENTIONAL DEVICES AND STENT IMPLANTATION MAY LEAD TO A SLOWING OR STOPPAGE OF BLOOD FLOW TO THE DOWNSTREAM VESSELS AND STRUCTURES OF THE BRAIN CAUSING INFARCTIONS OF THESE STRUCTURES. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00205 AND 1058196-2011-00206.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE ASSISTED WITH ENTERPRISE STENT, THE ENTERPRISE 4.5X22 STENT WAS IMPLANTED AFTER PROWLER SELECT PLUS WAS POSITIONED. THE DELIVERING PROCESS WAS SUCCESSFUL, BUT THE DISTAL AND PROXIMAL MARKS COULD NOT BEEN SEEN WHEN THE STENT WAS GOING TO BE RELEASED, BUT THE STENT WAS RELEASED. THE MICROGUIDE CATHETER WAS REMOVED AND TRUFILL COIL (638MF0407) WAS DETACHED USING THE MICROCATHETER, ONLY TO FIND THERE WAS NO STENT SUPPORTING THE NECK. HOWEVER, THE STENT COULD NOT BE FOUND ON DSA TEST OR IN CT TEST. THE DECISION WAS MADE TO IMPLANT ANOTHER ENTERPRISE (ENC452812) STENT WITH MARKERS COULD BE SEEN CLEARLY. FOUR ORBIT COILS (637MF0304, 637HF0206, 637HF0204, AND 637HF0204) WERE IMPLANTED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT SUFFERED SEVERE INFARCTION OF THE BRAIN APPROXIMATELY SIX DAYS AFTER THE PROCEDURE AND EXPIRE.

    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 01425624

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R COILS AND ENTERPRISE STENT