BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1854148 · Received October 5, 2010

    Report

    Report Number
    1058196-2010-00284
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 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

    PER LAKE REGION REPORT C9465- LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01421602. 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. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00284 & 1058196-2010-00285.

    Additional Manufacturer Narrative · 1

    A NON STERILE ENTERPRISE AND A PROWLER MICROCATHETER WERE RECEIVED FOR ANALYSIS. THE ENTERPRISE INCLUDING THE STENT) WAS STUCK INSIDE OF THE PROWLER MICROCATHETER. ABOUT 2MM OF THE STENT DISTAL END PROTRUDED FROM THE MICROCATHETER DISTAL TIP. BLOOD RESIDUALS WERE OBSERVED ON THE STENT. ONCE THE ENTERPRISE COULD BE REMOVED FROM THE MICROCATHETER, ACCUMULATION OF BLOOD RESIDUALS WERE OBSERVED ALONG THE ENTERPRISE SYSTEM. THE STENT WAS INSPECTED UNDER A MICROSCOPE AND NO DAMAGES WERE NOTED. NO FUNCTIONAL TEST COULD BE PERFORMED ON THE RECEIVED PRODUCT BECAUSE OF THE BLOOD ACCUMULATED ALONG THE WHOLE ENTERPRISE SYSTEM. (B)(6) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01421602. 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 (B)(6) 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. THE FAILURE STENT - INABILITY TO RECAPTURE WAS CONFIRMED SINCE THE RECEIVED CONDITION OF THE PRODUCT; BLOOD ACCUMULATION WAS OBSERVED ON THE STENT AS WELL AS THE WHOLE DELIVERY WIRE; THIS CONDITION IMPEDED THE STENT TO BE RECAPTURE. THE EXACT CAUSE OF THE ISSUES REPORTED COULD NOT BE CONCLUSIVELY DETERMINED. CLINICAL AND PROCEDURAL FACTORS APPEAR TO HAVE IMPACTED ON THE FAILURE EXPERIENCED BY THE CUSTOMER. 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 REVIEWS SUGGEST THAT THE FAILURE COULD BE RELATED TO THE ENTERPRISE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00284 AND 1058196-2010-00285. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AFTER ADVANCING THE ENTERPRISE VRD (ENC452212) TO THE TARGET SITE THROUGH A PROWLER SELECT PLUS (606S255FX), DURING THE INITIAL RECAPTURE OF THE ENTERPRISE, IT WAS STUCK. THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE MICROCATHETER. THE DEVICE WAS EXCHANGED TO ANOTHER NEW PRODUCT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS STABLE. THE PROCEDURE WAS A STENT ASSISTED COIL EMBOLIZATION OF AN INTERNAL CAROTID (IC)-POSTERIOR COMMUNICATING (PC) ANEURYSM IN A (B)(6) FEMALE WITH MODERATE VESSEL TORTUOSITY. IT IS NOT KNOWN IF THE MICROCATHETER WAS RESHAPED PRIOR TO USE OR IF THERE WAS ANY RESISTANCE AT ANY TIME PRIOR TO THE ATTEMPTED RECAPTURE. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. DURING DEPLOYMENT, THE MICROCATHETER WAS PLACED JUST DISTAL TO THE ANEURYSM NECK, AND ONCE THE ENTERPRISE WAS ADVANCED AND POSITIONED AT THE SITE, THE MC WAS WITHDRAWN TO EXPOSE THE STENT. HOWEVER, DURING DEPLOYMENT, ADJUSTMENT WAS NEEDED TO POSITION THE ENTERPRISE. FURTHER DETAILS REGARDING THIS ARE NOT KNOWN. THE RECAPTURED POINT WAS NOT EXCEEDED, AND DURING RECAPTURING, THE MICROCATHETER WAS ADVANCED OVER THE DELIVERY SYSTEM/VRD. CONSTANT FLUOROSCOPY WAS PERFORMED AT ALL TIMES DURING THE DELIVERY AND RECAPTURING. THE CORRECT MC WAS MOVE WHEN RECAPTURING. THE ENTERPRISE HAD NOT BEEN RECAPTURED PRIOR TO THIS. IT IS NOT KNOWN IF THERE WAS RESISTANCE AT ANYTIME DURING THE PROCEDURE PRIOR TO THE ATTEMPT TO RECAPTURE. PROCEDURAL IMAGES ARE NOT AVAILABLE. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF ENTERPRISE LOT 01421602. 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 THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. A NON STERILE PROWLER SELECT MICROCATHETER AND AN ENTERPRISE WERE RECEIVED COILED INSIDE A PLASTIC BAG AND Y CONNECTOR WAS STILL ATTACHED TO THE MICROCATHETER'S HUB. THE WHOLE ENTERPRISE (INCLUDING THE STENT) WAS RECEIVED INSERTED AND STUCK INSIDE OF THE MICROCATHETER PROWLER SELECT CATHETER. ABOUT 2MM OF THE STENT DISTAL END PROTRUDED FROM THE MICROCATHETER'S DISTAL TIP. BLOOD RESIDUALS WERE OBSERVED ON THE STENT. NO ANOMALIES WERE NOTED IN THE MICROCATHETER'S SHAFT. DISTAL END OF THE MICROCATHETER WHERE THE STENT WAS PROTRUDING WAS INSPECTED UNDER MICROSCOPE AND COULD BE OBSERVED THAT THE STENT COULD NOT BE COMPLETELY CLOSED ON THE DISTAL SIDE DUE TO THE RESIDUES OF BLOOD. ENTERPRISE COULD NOT BE RETRIEVED DUE TO THE STENT REMAINS STUCK IN THE DISTAL END OF THE MICROCATHETER, THEREFORE, ENTERPRISE WAS PUSHED AND AT THIS TIME THE STENT CAME OUT AS WELL AS RESIDUES OF BLOOD; DEVICE WAS COMPLETELY REMOVED AND SEVERAL RESIDUES OF BLOOD COULD BE OBSERVED ALONG THE WHOLE ENTERPRISE SYSTEM. THE STENT WAS INSPECTED UNDER A MICROSCOPE AND NO DAMAGES WERE NOTED. ANOTHER ENTERPRISE CORDIS LAB SAMPLE WAS INSERTED IN THE MICROCATHETER WITH SOME FRICTION EXPERIENCED AT THE DISTAL END OF THE MICROCATHETER DUE TO THE RESIDUES OF BLOOD THAT REMAINED IN THE INNER LUMEN. THE ID OF THE MICROCATHETER WAS MEASURED AND WAS FOUND WITHIN SPECIFICATION. THE REPORTED INABILITY TO RECAPTURE THE ENTERPRISE VRD IN THE PROWLER SELECT PLUS WAS CONFIRMED. WITH FUNCTIONAL ANALYSIS OF THE RETURNED DEVICES, THE CAUSE WAS THE DRIED BLOOD ACCUMULATED IN THE INNER LUMEN OF THE MICROCATHETER. AN INADEQUATE FLUSH DURING THE PROCEDURE MAY HAVE CONTRIBUTED TO THIS FINDING. THE DEVICE DID NOT PRESENT WITH ANY DEFECT OR INDICATION OF ANY MANUFACTURING ANOMALY THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, PROCEDURAL FACTORS MAY HAVE IMPACTED THE INABILITY TO RECAPTURE THE ENTERPRISE IN THE PROWLER SELECT MICROCATHETER. BASED ON THE ANALYSIS OF THE RETURNED DEVICES AND DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION OF ANY MANUFACTURING RELATED ISSUES CONTRIBUTING TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2010-00284 AND 1058196-2010-00285.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION FOR ANEURYSM OF THE IC-PC WITH MODERATE VESSEL TORTUOSITY, AND UNKNOWN CALCIFICATION. THE ENTERPRISE (B)(4) WAS ADVANCED THROUGH A (MC) MICROCATHETER (PROWLER SELECT PLUS, (B)(4)) TO THE TARGET LESION. DURING THE INITIAL RECAPTURING OF THE ENTERPRISE, IT WAS STUCK SO THE DEVICE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE MC. THE DEVICE WAS EXCHANGED TO OTHER NEW PRODUCT (DETAILS UNKNOWN) AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS STABLE. THE COMPLAINT PRODUCT WILL BE RETURNED TO YOUR SIDE TOGETHER WITH THE MC FOR ANALYSIS. THE ENTERPRISE STENT WAS ONLY RECAPTURED ONCE. DURING DEPLOYMENT, THE MC WAS PLACED JUST DISTAL TO THE ANEURYSM NECK, AND ONCE THE ENTERPRISE WAS ADVANCED AND POSITIONED AT THE SITE, THE MC WAS REMOVE TO EXPOSE THE STENT. HOWEVER, DURING DEPLOYMENT ADJUSTMENT WAS NEEDED TO POSITION THE ENTERPRISE, BUT DETAILS WERE UNKNOWN. THE RECAPTURED POINT WAS NOT EXCEEDED, AND DURING RECAPTURING, THE MICROCATHETER WAS ADVANCED OVER THE DELIVERY SYSTEM/VRD. CONSTANT FLUOROSCOPY WAS PERFORMED AT ALL TIMES DURING THE DELIVERY AND RECAPTURING. THE CORRECT MC WAS MOVE WHEN RECAPTURING. PRIOR TO RECAPTURING, THE MC WAS NOT PLACED AT AN ACUTE ANGLE. A CONSTANT AND DEDICATED SALINE SOURCE WAS UTILIZED AT ALL TIMES. THE PATIENT IS CURRENTLY IN STABLE CONDITION.

    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. 01421602

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR PROWLER SELECT PLUS.