BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 7557196 · Received May 31, 2018

    Report

    Report Number
    3001845648-2018-00255
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Report Date
    May 31, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    ESW
    UDI-DI
    10827002551715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510K#: K162717. 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: (B)(4). DEVICE EVALUATION: THE EVO-FC-R-20-25-10-E DEVICE OF LOT NUMBER: C1446990 WAS RETURNED TO COOK IRELAND FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE GRASPING FEATURE HAS THE PEAK TUBING THROUGH IT AND CANNOT BE RELEASED FROM THE INTRODUCER SYSTEM AS THE GRASPING FEATURE DOES NOT GO OVER THE TIP. THE TIP IS GLUED TO THE PEAK TUBING AFTER THE STENT HAS BEEN PLACED. THEREFORE THIS ISSUE IS DEEMED TO BE MANUFACTURING RELATED. THE PRODUCTION SUPERVISOR CONFIRMED THAT A NON-CONFORMANCE REVIEW HAS BEEN RAISED TO ADDRESS THIS EVENT. THE CUSTOMER COMPLAINT WAS CONFIRMED AS FAILURE WAS VERIFIED IN LABORATORY. THE PEAK TUBING WAS FOUND TO BE THROUGH THE GRASPING LOOP PREVENTING THE STENT FROM BEING RELEASED FROM THE INTRODUCER. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: 1. WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? VISIGLIDE. 2. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? EVO-FC-R-20-25-8-E. 3. FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH PATIENT) ALSO ASK: W HAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED DURING THE PROCEDURE? QLYMPUS, THE DEVICE IS NOT TTS. 4. HAD DILATION OF THE STRICTURE BEEN PERFORMED PRIOR TO STENT PLACEMENT? N.A. 5. WHAT WAS THE DIAMETER OF THE STRICTURE AT THE TIME OF STENT PLACEMENT (IN MM)? N.A. 6. WHAT WAS THE LENGTH OF THE STRICTURE AT THE TIME OF STENT PLACEMENT (IN CM)? N.A. 7. PLEASE DESCRIBE THE LOCATION IN THE BODY WHERE THE STENT WAS TO BE PLACED. N.A. 8. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE STRICTURE? NO. 9. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCER AND STENT INTO POSITION? NO. 10. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE PATIENT? NO. 11. AFTER PLACEMENT, WAS STENT POSITION VERIFIED? IF YES, PLEASE DESCRIBE HOW. STENT COULDN'T BE DISCONNECTED FROM THE INTRODUCING SYSTEM. 12. AFTER PLACEMENT, WAS THE ENDOSCOPE ADVANCED THROUGH THE STENT? NO PLACEMENT. 13. PLEASE ESTIMATE AMOUNT OF TIME THE STENT WAS IN PLACE PRIOR TO THIS OCCURRENCE. NO, PLACEMENT. 14. DID THE PATIENT UNDERGO CHEMOTHERAPY OR RADIATION TREATMENTS AFTER STENT PLACEMENT? N.A. ROOT CAUSE: THE DEVICE WAS RETURNED AND EVALUATED AND A POSSIBLE CAUSE FOR THE EVENT WAS MANUFACTURING ERROR WHERE THE TIP IS GLUED TO THE PEAK TUBING AFTER THE STENT HAS BEEN PLACED, THIS RESULTED IN THE GRASPING FEATURE HAVING THE PEAK TUBING INSERTED THROUGH IT AND CANNOT BE RELEASED FROM THE INTRODUCER SYSTEM AS THE GRASPING FEATURE DOES NOT GO OVER THE TIP. PRODUCTION INSTRUCTION DID NOT CONTAIN A CHECK TO ENSURE THE PEEK TUBING HAD NOT PASSED THROUGH THE GRASPING FEATURE. RISK DOCUMENTS DID NOT CONSIDER A FAILURE MODE WHERE THE PEEK TUBING WOULD PASS THROUGH THE GRASPING FEATURE AD THEREFORE PREVENT STENT DEPLOYMENT. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL EVO-FC-R-20-25-10-E DEVICES ARE SUBJECTED TO A 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 QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THE LOT NUMBER: C1446990. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS EVIDENCE TO SUGGEST THAT THERE IS A MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER: C1446990 WHERE A NON-CONFORMANCE REVIEW HAS BEEN RAISED TO ADDRESS THIS EVENT. IFU REVIEW: AS PER 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". ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. SUMMARY: FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER STENT. THE CUSTOMER COMPLAINT WAS CONFIRMED AS FAILURE WAS VERIFIED IN THE LABORATORY. THE COMPLAINT WAS DEEMED TO BE MANUFACTURING RELATED AS THE GREEN GRASPING FEATURE ON THE PROXIMAL END HAD THE PEEK TUBING THROUGH IT, AND HENCE THE STENT COULD NOT BE RELEASED FROM THE INTRODUCER AS THE GRASPING FEATURE CANNOT GO OVER THE WHITE TIP OF THE DEVICE. 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. 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. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    REPORT IS BEING SUBMITTED UNDER THE PRECEDENCE FOR "DEPLOYMENT ISSUE WHICH RESULTS IN THE REMOVAL OF AN EXPOSED STENT WITH THE DELIVERY SYSTEM". PHYSICIAN WAS NOT ABLE TO RELEASE STENT FROM INTRODUCER SYSTEM. YES, THAT IS RIGHT. THE STENT IS STILL CONNECTED TO THE INTRODUCING SYSTEM. DURING THE IMPLANTATION THEY COULDN'T PULL THE SECURITY WIRE, SO THEY COULDN'T DISCONNECT THE STET FROM THE INTRODUCING SYSTEM. 1. WAS THE DIRECTIONAL BUTTON FULLY ENGAGED? YES. 2. DID THE RED CURSOR MOVE WHEN THE TRIGGER WAS PRESSED? YES. 3. DID THE RED CURSOR CONTINUE TO MOVE AFTER THE DELIVERY STOPPED? NO. 4. WERE ANY CRACKING/POPPING SOUNDS HEARD FROM THE HANDLE? NO. 5. WAS THE STENT PARTIALLY DEPLOYED? COMPLETE. 6. IF THE STENT WAS PARTIALLY EXPOSED, WAS IT POSSIBLE TO RETRACT IT FULLY BEFORE REMOVAL? THEY DON¿T TRIED IT. 6. WERE ANY ADDITIONAL PROCEDURES NEEDED? THE TOOK AN NEW STENT (8CM) WITH SUCCESS 7. WHAT IS THE PATIENT OUTCOME? OK.

    Description of Event or Problem · 0

    PHYSICIAN WAS NOT ABLE TO RELEASE STENT FROM INTRODUCER SYSTEM. YES ¿ THAT IS RIGHT. THE STENT IS STILL CONNECTED TO THE INTRODUCING SYSTEM "AS PER COMPLAINT FORM": DURING THE IMPLANTATION THEY COULDN'T PULL THE SECURITY WIRE, SO THEY COULDN'T DISCONNECT THE STET FROM THE INTRODUCING SYSTEM. 1. WAS THE DIRECTIONAL BUTTON FULLY ENGAGED? YES. 2. DID THE RED CURSOR MOVE WHEN THE TRIGGER WAS PRESSED? YES. 3. DID THE RED CURSOR CONTINUE TO MOVE AFTER THE DELIVERY STOPPED? NO. 4. WERE ANY CRACKING/POPPING SOUNDS HEARD FROM THE HANDLE? NO. 5. WAS THE STENT PARTIALLY DEPLOYED? COMPLETE. 6. IF THE STENT WAS PARTIALLY EXPOSED, WAS IT POSSIBLE TO RETRACT IT FULLY BEFORE REMOVAL? THEY DIDN¿T TRY IT. 6. WERE ANY ADDITIONAL PROCEDURES NEEDED? THE TOOK AN NEW STENT (8 CM) WITH SUCCESS. 7. WHAT IS THE PATIENT OUTCOME? OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398615 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW COOK IRELAND LTD C1446990 10827002551715

    Patients

    Seq Age Sex Outcome Treatment
    1