BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2450813 · Received February 14, 2012

    Report

    Report Number
    1058196-2012-00080
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 3, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2012-00080 AND 1058196-2012-00081.

    Additional Manufacturer Narrative · 1

    WHEN ATTEMPTING TO DEPLOY A 22MM ENTERPRISE S VRD, DURING THE DEPLOYMENT THE PROWLER SELECT PLUS DELIVERY CATHETER SLIDE BACK SO THE STENT WAS RECAPTURED ONCE; BUT DURING ITS RECAPTURE SOME RESISTANCE WAS FELT. THE STENT WAS DEPLOYED SLIGHTLY MORE TO RELIEVE SOME PRESSURE AND THEN WAS ABLE TO FULLY RECAPTURE THE STENT. THE PROWLER SELECT PLUS WAS THEN SUCCESSFULLY NAVIGATED BACK INTO POSITION AND THE STENT WAS BEING REINTRODUCED TO THE PROWLER WHEN A LOT OF FORCE PUSHED BACK THE INTRODUCER AND THE STENT DEPLOYED IN THE PROWLER SELECT PLUS. THE PHYSICIAN REPORTED THAT IT WAS THOUGHT THAT DURING THE RECAPTURE WHEN TENSION WAS FELT THE DISTAL STENT TINES MAY HAVE BEEN DAMAGED AND LOCKED ON EACH OTHER CAUSING A PROBLEM DURING REINTRODUCTION OF THE STENT INTO THE PROWLER SELECT PLUS. THE DEVICES WERE REMOVED FROM THE PATIENT AND THE CASE WAS COMPLETED WITHOUT ISSUE WITH A SECOND 22MM ENTERPRISE VRD AND ANOTHER MC. THE PATIENT HAD A SUCCESSFUL TREATMENT AND IS DOING WELL. THE PROCEDURE WAS TREATMENT OF AN OBLONG ANEURYSM IN THE POSTERIOR COMMUNICATING (PCOM) ARTERY. NO ADDITIONAL TORQUE WAS UTILIZED DURING THE POSITIONING OR TO ACHIEVE A BETTER LOCATION WITH THE ENTERPRISE SYSTEM OR AT ANY OTHER TIME. THERE WERE NO KINKS IN THE MC CONTRIBUTING TO THE EVENT. AFTER REMOVAL FROM THE PATIENT THERE WERE NO DAMAGES NOTED ON THE DEVICES. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00080 AND 1058196-2012-00081. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10010271. 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 ENTERPRISE STENT WAS RECEIVED IN THE HUB OF THE RETURNED PROWLER SELECT PLUS MICROCATHETER (MC). THE ENTERPRISE DELIVERY SYSTEM WAS NOT RECEIVED. THE STENT WAS LOCATED DEPLOYED STUCK INTO THE MC HUB'S. DRY BLOOD RESIDUALS WERE OBSERVED INTO THE MICROCATHETER HUB AT NAKED EYE. ONCE THE STENT WAS REMOVED FROM THE MC HUB, IT WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE DETECTED ON IT. THE DEPLOYMENT PROCESS COULD NOT BE PERFORMED WITH THE ENTERPRISE DEVICE USE PROCEDURALLY SINCE ONLY THE DEPLOYED STENT WAS RECEIVED. DEPLOYMENT OF THE ENTERPRISE STENT IN THE MC HUB WAS CONFIRMED. WITH ANALYSIS OF THE RETURNED ENTERPRISE STENT THERE WERE NO DAMAGES NOTED ON THE STENT. FURTHER ANALYSIS INCLUDING FUNCTIONAL TESTING OF THE ENTERPRISE SYSTEM IS NOT POSSIBLE SINCE THE DELIVERY SYSTEM WAS NOT RETURNED. BASED ON THE AVAILABLE CLINICAL/PROCEDURAL INFORMATION AND THE ANALYSIS OF THE RETURNED DEVICE; NO CONCLUSION CAN BE MADE REGARDING THE REPORTED EVENT. THE DEVICE DID NOT PRESENT WITH ANY MANUFACTURING DEFECTS OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE HISTORY RECORDS INDICATE THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE NO ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00080 AND 1058196-2012-00081.

    Additional Manufacturer Narrative · 1

    A PROWLER SELECT PLUS MICRO CATHETER (MC) WAS RECEIVED INSIDE OF A PLASTIC BAG. NO ENTERPRISE VRD AND DELIVERY WIRE WERE RECEIVED FOR ANALYSIS. THE STENT WAS LOCATED DEPLOYED STUCK INTO THE MC HUB'S. DRY BLOOD RESIDUALS WERE OBSERVED INTO THE MICROCATHETER HUB AT NAKED EYE. THE MICROCATHETER HUB WAS OBSERVED UNDER MICROSCOPE AND VISUAL SYSTEM. THE STENT WAS CONFIRMED DEPLOYED STUCK INTO THE MICROCATHETER HUB. ONCE THE STENT COULD BE REMOVED FROM THE MC HUB, WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE DETECTED ON IT. THE DEPLOYMENT PROCESS COULD NOT BE PERFORMED SINCE THE ENTERPRISE VRD AND DELIVERY WIRE WERE NOT RECEIVED FOR ANALYSIS AND THE STENT WAS RECEIVED DEPLOYED INTO THE MICROCATHETER HUB. ACCORDING TO THE DP 12158508 IS NECESSARY THAT THE STENT IS STILL INSIDE THE INTRODUCER TUBE. CORDIS LOT # 10010271 IS LAKE REGION LOT # 10010271. PER LAKE REGION REPORT (B)(4) LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10010271. 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 REPORTED FAILURE BY THE CUSTOMER "DELIVERY WIRE / RESISTANCE/FRICTION" COULD NOT BE EVALUATED, SINCE THE ENTERPRISE VRD AND DELIVERY WIRE WAS NOT RECEIVED FOR ANALYSIS. THE REPORTED FAILURE "STENT / DAMAGED" WAS NOT CONFIRMED, SINCE ONCE THE STENT COULD BE REMOVED FROM THE MC HUB, THIS WAS INSPECTED UNDER MICROSCOPE AND NO DAMAGES WERE DETECTED ON IT. THE REPORTED FAILURE "STENT / DEPLOYMENT DIFFICULTY-PREMATURE DEPLOYMENT" WAS CONFIRMED, OWING TO THE RECEIVED CONDITION OF THE DEVICE; THE STENT WAS RECEIVED DEPLOYED STUCK INTO THE MICROCATHETER HUB. THE CAUSE OF EVENTS EXPERIENCED BY THE CUSTOMER DURING PREPARATION OF THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE DID NOT PRESENT ANY OBVIOUS MANUFACTURING DEFECTS OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO FAILURE AS REPORTED. THE DEVICE HISTORY RECORDS INDICATE THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT; THEREFORE, NO ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00080 AND 1058196-2012-00081. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A NEUROVASCULAR PROCEDURE, THE ENTERPRISE VRD (ENC452212/10010271) WAS ATTEMPTED TO BE DEPLOY, BUT DURING THE DEPLOYMENT, THE PROWLER SELECT PLUS DELIVERY MICROCATHETER (606-S255X/LOT UNK) SLID BACK, SO THE STENT WAS RECAPTURED ONCE BUT DURING ITS RECAPTURE THE PHYSICIAN FELT SOME RESISTANCE, AND THE STENT WAS DEPLOYED SLIGHTLY MORE TO RELIEF SOME PRESSURE AND THEN WAS ABLE TO FULLY RECAPTURED. THE PROWLER SELECT PLUS WAS THEN SUCCESSFULLY NAVIGATED BACK INTO POSITION AND THE STENT WAS BEING REINTRODUCED TO THE PROWLER WHEN A LOT OF FORCE WAS NOTED, AND IT PUSHED BACK THE INTRODUCER AND THE STENT DEPLOYED IN THE PROWLER SELECT PLUS. IT IS BELIEVED THAT DURING THE RECAPTURE WHEN TENSION WAS FELT, THE DISTAL STENT TYNES GOT DAMAGED AND LOCKED ON EACH OTHER CAUSING A PROBLEM DURING REINTRODUCTION OF THE STENT INTO THE MICROCATHETER. PRIOR TO REPOSITIONING THE MICROCATHETER, THE ENTERPRISE WAS COMPLETELY REMOVED FROM THE MICROCATHETER/PATIENT, AND GUIDEWIRE WAS USED TO POSITION THE MICROCATHETER AT THE TARGET SITE. THE ENTERPRISE DELIVERY SYSTEM WAS NOT UTILIZED LIKE A GUIDEWIRE TO REPOSITION THE MICROCATHETER. DURING THE POSITIONING OR AT ANY OTHER TIME, NO ADDITIONAL TORQUE WAS UTILIZED TO ACHIEVE BETTER LOCATION WITH THE ENTERPRISE DELIVERY SYSTEM, AND THE ENTERPRISE SYSTEM WAS NOT LEFT IN THE VESSEL, WHILE THE MICROCATHETER WAS REPOSITIONED. THE MC WAS NOT RE-SHAPED PRIOR TO USE, AND THERE WERE NO KINKS IN THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE EVENT. AFTER THE EVENT, THE SAME MICROCATHETER WAS NOT UTILIZED TO COMPLETE THE PROCEDURE, AND IT IS GOING TO BE RETURNED FOR ANALYSIS. THE TARGET SITE WAS THE PCOM ARTERY WITH AN OBLONG ANEURYSM. AFTER REMOVAL FROM THE PATIENT, NEITHER DEVICE (DISTAL TIP-UNRAVELED, STRETCHED, KINK, BEND, FRACTURE, DETACHED, ETC), STENT (KINK, BEND, FRACTURE, SEPARATED, UPLIFTED STRUTS, ETC), INTRODUCER OR MICROCATHETER WERE DAMAGED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 22MM ENTERPRISE.

    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 10010271

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER SELECT PLUS