BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2895338 · Received January 3, 2013

    Report

    Report Number
    1058196-2012-00440
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    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

    PLEASE NOTE THAT THE CORRECT ALERT DATE FOR FOLLOW-UP 1 MEDWATCH REPORT IS (B)(4) 2012. ADDITIONALLY, PLEASE NOTE THAT THE SAME INFORMATION REPORTED UNDER THIS MEDWATCH REPORT (1058196-2012-00440) BELONGS TO MEDWATCH REPORT 1058196-2012-00441. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00440 AND 1058196-2012-00441.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00440 AND 1058196-2012-00441.

    Additional Manufacturer Narrative · 1

    DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ENTERPRISE SYSTEM ((B)(4)) AT THE ANEURYSM NECK REGION, BUT THE STENT DIDN'T DEPLOY ALTHOUGH A COUPLE OF TIMES WERE ATTEMPTED BY WITHDRAWING THE PROWLER SELECT PLUS MICROCATHETER (MC). THE ENTERPRISE SYSTEM WAS REMOVED WITH THE PROWLER SELECT PLUS MICROCATHETER, AND TESTED ON THE SALINE TRAY. THE ENTERPRISE DEPLOYED FROM THE SHEATH IN THE AIR, AND ALSO TESTED THE PROWLER MICROCATHETER WITH A GUIDEWIRE WITHOUT ANY PROBLEMS. THEN, ANOTHER SAME SIZE ENTERPRISE WAS USED AND IT DID WORK WITH THE SAME MICROCATHETER. THERE WAS NO THROMBUS OR STENOSIS AT THE TARGET SITE THAT MAY HAVE CONTRIBUTED TO THE EVENT AND DURING THE ATTEMPT TO RELEASE THE DEVICE, THE DEVICE WAS NOT IN A SIDE BRANCH, BIFURCATION, OR AT AN ACUTE ANGLE. ALL LABELING GUIDELINES WERE FOLLOWED FOR INSERTION OF THE ENTERPRISE INTO THE Y CONNECTOR AND MICROCATHETER, AND A CONSTANT FLUOROSCOPY WAS PERFORMED AT ALL TIMES, AND NOTHING PREVENTED THE STENT FROM EXITING THE MICROCATHETER, ONLY THE TIP (12MM) OF THE DELIVERY SYSTEM WAS EXPOSED. DURING THE CASE, THE STENT WAS PLACED AT LEAST 5MM ON EITHER SIDE OF THE ANEURYSM NECK. THE MICROCATHETER DISTAL TIP WAS NOT RE-SHAPED. AFTER THE EVENT, OTHER THAN THE REPORTED EVENT, NO OTHER DAMAGES WERE NOTED ON THE DEVICE (ENTERPRISE DELIVERY SYSTEM/DISTAL TIP (UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, SEPARATED, ETC), OR STENT (STRUT UPLIFT OR DEFORMED, ETC) OR MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY DONE WITHOUT ANY COMPLICATIONS, AND THE DEVICE WILL BE RETURN FOR ANALYSIS. ONE NON STERILE ENTERPRISE AND DELIVERY WIRE WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE ENTERPRISE STENT WAS NOT RECEIVED FOR ANALYSIS. THE DELIVERY WIRE WAS INSERTED IN THE INTRODUCER TUBE ON THE DISTAL SECTION. NO OTHER ANOMALIES WERE OBSERVED ON THE RECEIVED UNIT. THE FUNCTIONAL ANALYSIS WAS PERFORMING USING A LAB SAMPLE MICROCATHETER, THE DELIVERY WIRE WITHOUT STENT WAS INTRODUCED INTO THE MICROCATHETER AND IT WAS ABLE TO GO THROUGH THE MICROCATHETER (WITHOUT STENT) AND NO RESISTANCE OR FRICTION WAS FELT. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10106131. 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. THE MICROCATHETER WAS NOT RETURN FOR ANALYSIS, AND THE LOT NUMBER WAS NOT PROVIDED TO CONDUCT A DHR REVIEW. THE PROWLER SELECT PLUS MICROCATHETER WAS NOT RETURNED FOR ANALYSIS, BUT THE RESISTANCE/FRICTION AND INABILITY TO INSERT THE ENTERPRISE WAS NOT CONFIRMED WITH FUNCTIONAL TESTING WITH A LAB SAMPLE PROWLER SELECT PLUS MICROCATHETER. IT IS POSSIBLE THAT PROCEDURAL AND HANDLING FACTORS APPEAR TO BE CONTRIBUTED IN THE DAMAGE NOTED IN THE DEVICE AND IN THE REPORTED EVENT. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00440 AND 1058196-2012-00441.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE ENTERPRISE SYSTEM (ENF452212/1010613) AT THE ANEURYSM NECK REGION. BUT THE STENT DIDN'T DEPLOY ALTHOUGH A COUPLE OF TIMES WERE ATTEMPTED. THE ENTERPRISE SYSTEM WAS REMOVED WITH THE PROWLER SELECT PLUS MICROCATHETER, AND TESTED ON THE SALINE TRAY. THE ENTERPRISE DEPLOYED FROM THE SHEATH IN THE AIR, AND ALSO TESTED THE PROWLER MICROCATHETER WITH A GUIDEWIRE WITHOUT ANY PROBLEMS. THEN, ANOTHER SAME SIZE ENTERPRISE WAS USED AND IT DID WORK. THE PROCEDURE WAS SUCCESSFULLY DONE WITHOUT ANY COMPLICATIONS, AND THE DEVICE WILL BE RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3522 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 10106131

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER SELECT PLUS MICROCATHETER