BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1901315 · Received November 17, 2010

    Report

    Report Number
    1058196-2010-00340
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 22, 2010
    Report Date
    October 22, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PI NUMBER WAS CORRECTED. THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING AN INTERVENTIONAL PROCEDURE THE PHYSICIAN WAS NOT ABLE TO GET THE ENTERPRISE VRD AND DELIVERY STENT TO RE-SHIFT/RE-CAPTURE WHILE ATTEMPTING TO WITHDRAW THE ENTIRE SYSTEM AND A STENT STRUT GOT CAUGHT IN THE STENT LEAD-WIRE. A PROWLER SELECT PLUS MICRO-CATHETER WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS THE CAROTID ARTERY. NO TARGET LESION CHARACTERISTIC INFORMATION WAS PROVIDED. THE ENTERPRISE STENT WAS NOT IMPLANTED AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE/RE-CAPTURE THE SYSTEM FROM THE PATIENT. ANOTHER ENTERPRISE VRD AND DELIVERY STENT WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO PROBLEM REPORTED WITH THE PROWLER SELECT PLUS MICRO-CATHETER ALTHOUGH THERE MAY HAVE BEEN SOME RESISTANCE/FRICTION DURING ADVANCEMENT. IT WAS NOT KNOWN IF THE ENTERPRISE SYSTEM WAS ADVANCED PAST THE RE-CAPTURE POINT. NO ADDITIONAL INFORMATION WAS AVAILABLE. (B)(4): THE PRODUCT WAS RETURNED FOR INSPECTION. (B)(4) REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF ENTERPRISE VRD LOT M1423535. 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)(4) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. A NON-STERILE PROWLER SELECT PLUS WAS RECEIVED COILED INSIDE A PLASTIC BAG. AN ENTERPRISE VRD AND DELIVERY WAS RECEIVED INSERTED IN THE PROWLER SELECT PLUS CATHETER. ABOUT 3MM OF THE STENT DISTAL SECTION WAS PROTRUDING FROM THE PROWLER CATHETER DISTAL TIP. THE INVOLVED INTRODUCER SHEATH WAS NOT RETURNED. NO ANOMALIES WERE OBSERVED ON THE RECEIVED PRODUCTS. FUNCTIONAL TEST WAS PERFORMED PER PROCEDURE. USING AN INTRODUCER LAB SAMPLE THE STENT WAS RECAPTURED WITHOUT ANY DIFFICULTY. BLOOD TRACES WERE OBSERVED ON THE DELIVERY WIRE WHILE PERFORMING THE FUNCTIONAL TEST. THE REPORTED INABILITY TO RECAPTURE THE STENT WAS NOT CONFIRMED; WITH FUNCTIONAL TESTING OF THE RETURNED DEVICE IT WAS ABLE TO BE RECAPTURED INTO THE RECEIVED PROWLER SELECT PLUS MICROCATHETER AND INTO A LAB SAMPLE INTRODUCER WITHOUT ANY DIFFICULTY. THE INSTRUCTIONS FOR USE OUTLINES THAT IF STENT REPOSITIONING IS REQUIRED, GENTLY ADVANCE THE INFUSION CATHETER OVER THE DEPLOYED STENT (DO NOT PULL THE STENT BACK INTO THE INFUSION CATHETER), REPOSITION THE SYSTEM, AND RE-DEPLOY THE STENT IN THE NEW LOCATION. IT IS NOTED THAT WHEN ADVANCING THE INFUSION CATHETER OVER THE STENT DURING RECAPTURE, IT MAY BE NECESSARY TO KEEP THE STENT STABLE WITH TENSION ON THE DELIVERY WIRE. ANALYSIS RESULTS SUGGEST THAT PROCEDURAL FACTORS/VESSEL CHARACTERISTICS AND/OR HANDLING FACTORS APPEAR TO HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. WITH REVIEW OF THE FUNCTIONAL TESTING OF THE RETURNED DEVICES AND THE ENTERPRISE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF ANY MANUFACTURING RELATED ISSUES IMPACTING THE EVENT. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1058196-2010-00340 AND #1058196-2010-00341.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT #1058196-2010-00340 AND #1058196-2010-00341.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING AN INTERVENTIONAL PROCEDURE THE PHYSICIAN WAS NOT ABLE TO GET THE ENTERPRISE VRD AND DELIVERY STENT TO RE-SHIFT/RE-CAPTURE WHILE ATTEMPTING TO WITHDRAW THE ENTIRE SYSTEM AND A STENT STRUT GOT CAUGHT IN THE STENT LEAD-WIRE. A PROWLER SELECT PLUS MICRO-CATHETER WAS USED FOR THE PROCEDURE. THE TARGET LESION WAS THE CAROTID ARTERY. NO TARGET LESION CHARACTERISTIC INFORMATION WAS PROVIDED. THE ENTERPRISE STENT WAS NOT IMPLANTED AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE/RE-CAPTURE THE SYSTEM FROM THE PATIENT. ANOTHER ENTERPRISE VRD AND DELIVERY STENT WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO PROBLEM REPORTED WITH THE PROWLER SELECT PLUS MICRO-CATHETER ALTHOUGH THERE MAY HAVE BEEN SOME RESISTANCE/FRICTION DURING ADVANCEMENT. IT WAS NOT KNOWN IF THE ENTERPRISE SYSTEM WAS ADVANCED PAST THE RE-CAPTURE POINT. NO ADDITIONAL INFORMATION WAS AVAILABLE. (B)(4): THE PRODUCT WAS RETURNED FOR INSPECTION. THE LOT NUMBER OF THE PROWLER SELECT PLUS IS NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. A NON-STERILE PROWLER SELECT PLUS WAS RECEIVED COILED INSIDE A PLASTIC BAG. AN ENTERPRISE VRD AND DELIVERY WAS RECEIVED INSERTED IN THE PROWLER SELECT PLUS CATHETER. ABOUT 3MM OF THE STENT DISTAL SECTION WAS PROTRUDING FROM THE PROWLER CATHETER DISTAL TIP. THE INVOLVED INTRODUCER SHEATH WAS NOT RETURNED. NO ANOMALIES WERE OBSERVED ON THE RECEIVED PRODUCTS. FUNCTIONAL TEST WAS PERFORMED PER PROCEDURE. USING AN INTRODUCER LAB SAMPLE THE STENT WAS RECAPTURED WITHOUT ANY DIFFICULTY. BLOOD TRACES WERE OBSERVED ON THE DELIVERY WIRE WHILE PERFORMING THE FUNCTIONAL TEST. THE REPORTED INABILITY TO RECAPTURE THE STENT WAS NOT CONFIRMED; WITH FUNCTIONAL TESTING OF THE RETURNED DEVICE IT WAS ABLE TO BE RECAPTURED INTO THE RECEIVED PROWLER SELECT PLUS MICROCATHETER AND INTO A LAB SAMPLE INTRODUCER WITHOUT ANY DIFFICULTY. THE INSTRUCTIONS FOR USE OUTLINES THAT IF STENT REPOSITIONING IS REQUIRED, GENTLY ADVANCE THE INFUSION CATHETER OVER THE DEPLOYED STENT (DO NOT PULL THE STENT BACK INTO THE INFUSION CATHETER), REPOSITION THE SYSTEM, AND RE-DEPLOY THE STENT IN THE NEW LOCATION. IT IS NOTED THAT WHEN ADVANCING THE INFUSION CATHETER OVER THE STENT DURING RECAPTURE, IT MAY BE NECESSARY TO KEEP THE STENT STABLE WITH TENSION ON THE DELIVERY WIRE. ANALYSIS RESULTS SUGGEST THAT PROCEDURAL FACTORS/VESSEL CHARACTERISTICS AND/OR HANDLING FACTORS APPEAR TO HAVE CONTRIBUTED TO THE REPORTED CLINICAL EVENT. WITH REVIEW OF THE FUNCTIONAL TESTING OF THE RETURNED DEVICES AND THE ENTERPRISE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF ANY MANUFACTURING RELATED ISSUES IMPACTING THE EVENT. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #1058196-2010-00340 AND #1058196-2010-00341.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING AN INTERVENTIONAL PROCEDURE THE PHYSICIAN WAS NOT ABLE TO GET THE ENTERPRISE VRD AND DELIVERY STENT TO RE-SHIFT/RE-CAPTURE WHILE ATTEMPTING TO WITHDRAW THE ENTIRE SYSTEM AND A STENT STRUT GOT CAUGHT IN THE STENT LEAD-WIRE. A PROWLER SELECT PLUS MICRO-CATHETER WAS SUED FOR THE PROCEDURE. THE TARGET LESION WAS THE CAROTID ARTERY. NO TARGET LESION CHARACTERISTIC INFORMATION WAS PROVIDED. THE ENTERPRISE STENT WAS NOT IMPLANTED AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE/RE-CAPTURE THE SYSTEM FROM THE PATIENT. ANOTHER ENTERPRISE VRD AND DELIVERY STENT WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO PROBLEM REPORTED WITH THE PROWLER SELECT PLUS MICRO-CATHETER ALTHOUGH THERE MAY HAVE BEEN SOME RESISTANCE/FRICTION DURING ADVANCEMENT. IT WAS NOT KNOWN IF THE ENTERPRISE SYSTEM WAS ADVANCED PAST THE CAPTURE POINT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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 M1423535

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER SELECT PLUS MICRO-CATHETER