BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1960747 · Received January 14, 2011

    Report

    Report Number
    1058196-2011-00025
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A STENT ASSISTED COIL EMBOLIZATION PROCEDURE WHEN THE ENTERPRISE VRD WAS DEPLOYED TO THE RECAPTURE POINT VIA THE PROWLER SELECT PLUS MICROCATHETER AN ATTEMPT WAS MADE TO POSITION THE FIRST COIL (3.5X9 ORBIT MINI FILL) VIA A JAILED MICROCATHETER; HOWEVER, THE COIL COULD NOT BE PLACED SUCCESSFULLY BECAUSE THE SELECTED SIZE WAS NOT APPROPRIATE FOR THE ANEURYSM. THE COIL WAS REMOVED FROM THE MICROCATHETER WITHOUT INCIDENT. IT WAS REPORTED THAT THERE WAS NO COMPLAINT AGAINST THE COIL, AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE ENTERPRISE AND THE PROWLER SELECT MICROCATHETER WERE ACCIDENTLY REMOVED TOGETHER. NO RESISTANCE/ FRICTION OCCURRED AT ANY TIME BETWEEN THE MICROCATHETER AND ENTERPRISE SYSTEM/STENT. AFTER THE FIRST ENTERPRISE WAS REMOVED, THE SAME MICROCATHETER WAS UTILIZED TO PLACE ANOTHER ENTERPRISE AND OTHER COILS WERE PLACED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT. THE VERTEBRAL ARTERY ANEURYSM HAD A NECK OF 4.0MM, AND THE VESSEL DIAMETER PROXIMAL WAS 2.7MM AND DISTALLY WAS 2.6MM. NO FURTHER INFORMATION WAS AVAILABLE. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01423721. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, 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. ADDITIONAL DHR REVIEW FOR THE STENT PER NITINOL DEVICES & COMPONENTS (NDC) REVEALED THE INDIVIDUAL LOT FOLDERS WERE REVIEWED FOR ANY NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT. NO NON-CONFORMANCES RELATED TO THE REPORTED DEFECT WERE FOUND. THE ENTERPRISE STENTS LOTS INVOLVED IN THIS COMPLAINT MET ALL PURCHASE, MANUFACTURING AND QUALITY CONTROL SPECIFICATIONS WHEN SHIPPED TO LAKE REGION. THE INSTRUCTIONS FOR USE OUTLINES THE COMPLETED DEPLOYMENT OF THE ENTERPRISE VRD PRIOR TO COIL EMBOLIZATION. IT FURTHER OUTLINES THAT IN DEPLOYING THE ENTERPRISE 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. ALTHOUGH THE DEVICE IS NOT AVAILABLE FOR ANALYSIS, BASED ON THE REPORTED PROCEDURAL INFORMATION AND AS REPORTED, THE ENCOUNTERED DEPLOYMENT DIFFICULTY OF THE ENTERPRISE VRD IS RELATED TO USER HANDLING AND MISTAKENLY REMOVING THE ENTERPRISE AND MICROCATHETER. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    ANOTHER ENTERPRISE WAS PLACED WITH THE SAME MICROCATHETER. HOWEVER, THE SAME COIL (ORBIT MF 3.5X9MM-(CATALOG#/LOT # UNKNOWN)) WAS NOT POSITIONED AT THE SITE AFTER THE SECOND STENT WAS PLACED AT THE ANEURYSM NECK. INSTEAD OTHER COILS WERE PLACED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT. THE ANEURYSM SIZE WAS NECK 4.0MM, AND THE VESSEL DIAMETER PROXIMAL WAS 2.7MM AND DISTALLY WAS 2.6MM. A JAILING TECHNIQUE WAS UTILIZED FOR THIS CASE. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A COIL EMBOLIZATION PROCEDURE ASSISTED WITH THE VRD STENT (ENTERPRISE VRD AND DELIVERY, ENC452212) FOR AN ANEURYSM OF THE VERTEBRAL ARTERY, AN ATTEMPT WAS MADE TO POSITION THE FIRST COIL (ORBIT MF 3.5X9MM AT THE POINT THAT THE VRD WAS DEPLOYED TO THE RECAPTURE LIMIT. HOWEVER THE COIL COULD NOT BE PLACED SUCCESSFULLY BECAUSE THE SIZE WAS NOT APPROPRIATE FOR THE ANEURYSM AND WAS WITHDRAWN IN THE MICROCATHETER. THERE WAS NO COMPLAINT AGAINST THE COIL, AND IT WILL NOT BE RETURNED FOR ANALYSIS. THE COIL REMAINED ATTACHED TO THE DELIVERY SYSTEM. DURING THE ATTEMPT TO DETACH THE ENTERPRISE STENT, CONSTANT FLUOROSCOPY WAS PERFORMED, HOWEVER DURING THE ATTEMPT TO DETACH THE ENTERPRISE STENT, THE ENTERPRISE SYSTEM/STENT AND MICROCATHETER (PROWLER SELECT PLUS STR) WERE REMOVED TOGETHER BY ACCIDENT. NO RESISTANCE/ FRICTION OCCURRED AT ANY TIME BETWEEN THE MICROCATHETER AND ENTERPRISE SYSTEM/STENT. AFTER THE FIRST ENTERPRISE WAS REMOVED, THE SAME MICROCATHETER WAS UTILIZED WITH THE NEXT ENTERPRISE SYSTEM.

    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 01423721

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR PROWLER SELECT PLUS STR AND ORBIT COIL