BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3113846 · Received May 15, 2013

    Report

    Report Number
    1058196-2013-00133
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 23, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURN FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE ENTERPRISE DELIVERY SYSTEM (ENF452812/ 10195433) WAS PULLED OUT FROM THE DISTAL TIP OF SELECT PLUS 150/5 CM 45 SHAPE (606S255FX/ 15748667) MICROCATHETER (MC), BUT THERE WAS NO ENTERPRISE SYSTEM. ADDITIONALLY, THE ORBIT MINI COMPLEX COIL (637MF0202/15576556) STRETCHED DURING INSERTION INTO THE TARGET ANEURYSM, AND AFTER THE EVENT THE SAME SL 10 MICROCATHETER WAS USED WITH THE NEXT DEVICE. THERE WAS ONLY DELIVERY WIRE. ACCORDING TO THE REPORT, SINCE THERE WAS NO ENTERPRISE SYSTEM, THE MC MIGHT BE RELATED TO THE ISSUE. THEREFORE, THE MC SHOULD BE INSPECTED WITH THE DELIVERY SYSTEM. AFTER THE EVENT WITH THE ENTERPRISE, BOTH DEVICES (ENTERPRISE AND MICROCATHETER) WERE REMOVED AS A UNIT. PRIOR TO INSERTING IN THE PATIENT, IT WAS UNKNOWN IF THE ENTERPRISE STENT WAS PRESENT, BUT THERE WERE NO DAMAGES NOTICED ON THE MICROCATHETER OR ENTERPRISE THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. ALL GUIDELINES WERE FOLLOWED DURING INSERTION OF THE ENTERPRISE, AND NO ISSUES REPORTED DURING INITIAL INSERTION OR ADVANCING OF THE ENTERPRISE THROUGH THE Y CONNECTOR OR MICROCATHETER. THE STENT WAS NEVER FOUND, AND THE MICROCATHETER WAS NOT RE-SHAPED. DURING PLACEMENT, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE SL-10MICROCATHETER WAS REPOSITIONED, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER. NO RESISTANCE/FRICTION WAS NOTED BETWEEN THE COIL SYSTEM AND MICROCATHETER. OTHER THAT WHAT WAS REPORTED, NO OTHER DAMAGES NOTICED ON THE DEVICES (KINK, BEND, CRACK, SEPARATED, FRACTURE, ETC). THERE WAS NO ADVERSE EVENT, AND THE MICROCATHETER AND COIL WERE SUPPOSED TO BE RETURNED, BUT TO DATE NO PRODUCTS WERE RECEIVED. PER (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10195433. 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. 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 15748667 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED FAILURE VRD PREMATURE DEPLOYMENT COULD NOT BE EVALUATED SINCE THE DEVICES WERE NOT RECEIVED FOR ANALYSIS. THE EXACT CAUSE OF THE EVENT EXPERIENCED BY THE CUSTOMER COULD NOT BE CONCLUSIVELY DETERMINED; IT IS POSSIBLE THAT PROCEDURE FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE HISTORY DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. (B)(4).

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE ENTERPRISE DELIVERY SYSTEM (ENF452812/ 10195433) WAS PULLED OUT FROM THE DISTAL TIP OF SELECT PLUS 150/5 CM 45 SHAPE (606S255FX/ 15748667) MICROCATHETER (MC), BUT THERE WAS NO ENTERPRISE SYSTEM. ADDITIONALLY, THE ORBIT MINI COMPLEX COIL (637MF0202/15576556) STRETCHED DURING INSERTION INTO THE TARGET ANEURYSM, AND AFTER THE EVENT THE SAME SL 10 MICROCATHETER WAS USED WITH THE NEXT DEVICE. THERE WAS ONLY DELIVERY WIRE. ACCORDING TO THE REPORT, SINCE THERE WAS NO ENTERPRISE SYSTEM, THE MC MIGHT BE RELATED TO THE ISSUE. THEREFORE, THE MC SHOULD BE INSPECTED WITH THE DELIVERY SYSTEM. AFTER THE EVENT WITH THE ENTERPRISE, BOTH DEVICES (ENTERPRISE AND MICROCATHETER) WERE REMOVED AS A UNIT. PRIOR TO INSERTING IN THE PATIENT, IT WAS UNKNOWN IF THE ENTERPRISE STENT WAS PRESENT, BUT THERE WERE NO DAMAGES NOTICED ON THE MICROCATHETER OR ENTERPRISE THAT MIGHT HAVE CONTRIBUTED TO THE EVENT. ALL GUIDELINES WERE FOLLOWED DURING INSERTION OF THE ENTERPRISE, AND NO ISSUES REPORTED DURING INITIAL INSERTION OR ADVANCING OF THE ENTERPRISE THROUGH THE Y CONNECTOR OR MICROCATHETER. THE STENT WAS NEVER FOUND, AND THE MICROCATHETER WAS NOT RE-SHAPED. DURING PLACEMENT, THE COIL WAS NOT LEFT IN THE ANEURYSM, WHILE THE SL-10MICROCATHETER WAS REPOSITIONED, AND A CONSTANT AND DEDICATED HEPARINIZED SALINE SOURCE WAS UTILIZED AT ALL TIMES THROUGH THE MICROCATHETER. NO RESISTANCE/FRICTION WAS NOTED BETWEEN THE COIL SYSTEM AND MICROCATHETER. OTHER THAT WHAT WAS REPORTED, NO OTHER DAMAGES NOTICED ON THE DEVICES (KINK, BEND, CRACK, SEPARATED, FRACTURE, ETC). THERE WAS NO ADVERSE EVENT, AND THE MICROCATHETER AND COIL WILL BE RETURNED FOR ANALYSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215459 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 10195433

    Patients

    Seq Age Sex Outcome Treatment
    1 SELECT PLUS MICROCATHETER