BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6727625 · Received July 20, 2017

    Report

    Report Number
    3001845648-2017-00288
    Event Type
    Malfunction
    Date Received
    July 20, 2017
    Date of Event
    April 12, 2017
    Report Date
    June 19, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480282
    PMA / PMN Number
    K113510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195 IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113 PMA/510(K) #K113510 / K163468 ON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THE STENT WAS FULLY RETRACTED INTO THE SHEATH ON RETURN. THE RED SHUTTLE DEPLOYMENT MARKER WAS AT THE BACK OF THE HANDLE AND NO LOCKWIRE WAS RETURNED. THE HANDLE WAS DISMANTLED DURING LAB EVALUATION TO SHOW THAT THE FLEXOR HAD BROKEN AT THE SHUTTLE CAP. THE STENT WAS MANUALLY DEPLOYED AND WAS NOTED TO BE FINE. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS BROKEN AT THE SHUTTLE CAP, HOWEVER, IT MAY BE NOTED THAT USER ERROR MAY HAVE BEEN A CONTRIBUTORY FACTOR. AS USAGE CONDITION CANNOT BE REPLICATED WITHIN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. PRIOR TO DISTRIBUTION ALL EVO-25-30-8-C DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVOLUTION DEVICE OF LOT C1162472 REVEALED NO DISCREPANCIES IN THE MANUFACTURING RECORDS THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". ALSO: "INTRODUCE DELIVERY SYSTEM IN SHORT INCREMENTS OVER WIRE GUIDE, INTO ACCESSORY CHANNEL, UNTIL IT IS ENDOSCOPICALLY VISUALIZED EXITING THE SCOPE." FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) #K113510 / K163468. THIS REPORT IS BEING SUBMITTED DUE CORRECTIONS: IT MAY BE NOTED THAT A PROJECT IRE0045-K HAS BEEN ASSIGNED TO PRODUCT DEVELOPMENT TO FURTHER INVESTIGATE STENT DEPLOYMENT ISSUES OF THIS NATURE IN AN EFFORT TO ELIMINATE FUTURE OCCURRENCES.

    Description of Event or Problem · 0

    THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY. INTERVENTIONAL RADIOLOGIST EXPERIENCED ISSUE WHILE DEPLOYING A COLONIC STENT: EVO-25-30-8-C LOT #C1162472. THIS CASE WAS DONE UNDER FLUOROSCOPY. WENT EASILY THROUGH THE STRICTURE OVER THE AMPLATZ GUIDE WIRE AND PROCEEDED WITH EVO-25-30-6-C HOWEVER EVEN AFTER FOLLOWING THE COMPLETE STEPS, THE STENT DID NOT COME OUT OF THE SHEATH.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED DUE CORRECTIONS. THIS REPORT FORMS PART OF A RETROSPECTIVE REVIEW OF OPEN COMPLAINTS FOR A NEW MALFUNCTION PRECEDENCE FOR THIS DEVICE FAMILY. INTERVENTIONAL RADIOLOGIST EXPERIENCED ISSUE WHILE DEPLOYING A COLONIC STENT: EVO-25-30-8-C LOT #C1162472. THIS CASE WAS DONE UNDER FLUOROSCOPY. WENT EASILY THROUGH THE STRICTURE OVER THE AMPLATZ GUIDE WIRE AND PROCEEDED WITH EVO-25-30-6-C HOWEVER EVEN AFTER FOLLOWING THE COMPLETE STEPS, THE STENT DID NOT COME OUT OF THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507675 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD G48028 10827002480282

    Patients

    Seq Age Sex Outcome Treatment
    1