BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED

    MDR report key: 7922497 · Received October 1, 2018

    Report

    Report Number
    3001845648-2018-00460
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    September 3, 2018
    Report Date
    October 25, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    ESW
    UDI-DI
    10827002480312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: 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: 3005580113 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: 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). PROBLEM STATEMENT: ¿THE USER ADVANCED THE DELIVERY SYSTEM OVER A WIRE GUIDE AND RELEASED THE WHOLE STENT AT THE TARGET SITE IN THE ESOPHAGUS WITHOUT NOTABLE RESISTANCE, AND THEN HE REMOVED THE SAFETY WIRE. HOWEVER THE PROXIMAL SIDE OF THE STENT WOULD NOT EXPAND. HE ATTEMPTED TO EXPAND IT BY POKING WITH FORCEPS BUT IT STILL DIDN'T EXPAND. HE GRASPED THE STENT USING FORCEPS AND REMOVED FROM THE PATIENT AND SUCCESSFULLY PLACED EVO-20-25-12.5-E INSTEAD TO COMPLETE THE PROCEDURE. WHEN THE USER CHECKED THE STENT AFTER THE PROCEDURE, THE PROXIMAL SIDE OF THE STENT EXPANDED.¿ ADDITIONAL INFORMATION: 1. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE STRICTURE? NO. 2. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCER AND STENT INTO POSITION? NO. 3. WAS DILATION OF THE STRICTURE COMPLETED PRIOR TO STENT PLACEMENT? NO. 4. WHAT WAS THE DIAMETER OF THE STRICTURE? (MM) 5MM. 5. WHAT WAS THE LENGTH OF THE STRICTURE? (CM) 6MM. 6. (ESOPHAGEAL ONLY) WAS THE STENT PLACED AT THE GASTROESOPHAGEAL JUNCTION? THE STENT IN QUESTION WAS GOING TO BE PLACED THERE. 7. WAS THE ENDOSCOPE ADVANCED INTO THE STENT AFTER PLACEMENT? NO. 8. DID THE PATIENT UNDERGO CHEMOTHERAPY OR RADIATION TREATMENTS AFTER STENT PLACEMENT? NO. AT WHAT POINT WAS THE LOCKWIRE REMOVED? IT WAS REMOVED AFTER WHOLE STENT WAS DEPLOYED AS NOT FOLLOWING THE IFU. AND THEN THE USER FOUND THE PROXIMAL SIDE OF THE STENT WAS NOT EXPANDED. WAS THERE AN ATTEMPT TO REMOVE THE INTRODUCER SYSTEM PRIOR TO REMOVING THE LOCKWIRE? NO. LAB EVALUATION: THE EVO-20-25-10-E DEVICE OF LOT NUMBER: C1391911 WAS RETURNED TO COOK IRELAND ON 11 SEPT 2018. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THERE WAS DAMAGE TO PROXIMAL END OF STENT. ALL DAMAGE LOCATED IN THE SAME SECTION OF PROXIMAL END OF STENT. DAMAGE TO THE PROXIMAL END OF BILUMEN. THE LOCK WIRE WAS NOT RETURNED WITH THIS DEVICE. DUE TO THE DAMAGE TO THE BILUMEN AND PROXIMAL END OF STENT THE POTENTIAL ROOT CAUSE IS THAT THE DEVICE WAS ATTEMPTED TO BE REMOVED PRIOR TO REMOVAL OF LOCK WIRE. ADDITIONAL QUESTIONS HAVE BEEN REQUESTED AND ANSWERED SEE BELOW QUESTIONS: AT WHAT POINT WAS THE LOCKWIRE REMOVED? IT WAS REMOVED AFTER WHOLE STENT WAS DEPLOYED AS NOT FOLLOWING THE IFU. AND THEN THE USER FOUND THE PROXIMAL SIDE OF THE STENT WAS NOT EXPANDED. WAS THERE AN ATTEMPT TO REMOVE THE INTRODUCER SYSTEM PRIOR TO REMOVING THE LOCKWIRE? NO. ROOT CAUSE: A POSSIBLE CAUSE FOR THIS COMPLAINT IS THE USER NOT FULLY REMOVING THE LOCK WIRE WHEN ATTEMPTING TO RELEASE THE STENT, RESULTING IN THE STENT STAYING ATTACHED TO THE DEVICE. SEE ADDITIONAL INFORMATION DESCRIPTION: ¿AT WHAT POINT WAS THE LOCK WIRE REMOVED? ¿ IT WAS REMOVED AFTER WHOLE STENT WAS DEPLOYED AS NOT FOLLOWING THE IFU. AND THEN THE USER FOUND THE PROXIMAL SIDE OF THE STENT WAS NOT EXPANDED¿. IT MAY BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE, (IFU0061-5), THE FOLLOWING IS STATED: ¿WHEN STENT POINT OF NO RETURN HAS BEEN PASSED, PULL SAFETY WIRE OUT OF THE DELIVERY HANDLE NEAR GUIDE WIRE PORT¿. THIS EVENT IS THEREFORE CONSIDERED USER ERROR. DOCUMENTS REVIEW: PRIOR TO DISTRIBUTION ALL EVO-20-25-8-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. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THE LOT NUMBER C1391911. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER: C1391911. SUMMARY: THE COMPLAINT IS CONFIRMED BASED THE LAB EVALUATION. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE USER ADVANCED THE DELIVERY SYSTEM OVER A WIRE GUIDE AND RELEASED THE WHOLE STENT AT THE TARGET SITE IN THE ESOPHAGUS WITHOUT NOTABLE RESISTANCE, AND THEN HE REMOVED THE SAFETY WIRE. HOWEVER THE PROXIMAL SIDE OF THE STENT WOULD NOT EXPAND. HE ATTEMPTED TO EXPAND IT BY POKING WITH FORCEPS BUT IT STILL DIDN'T EXPAND. HE GRASPED THE STENT USING FORCEPS AND REMOVED FROM THE PATIENT AND SUCCESSFULLY PLACED EVO-20-25-12.5-E INSTEAD TO COMPLETE THE PROCEDURE. WHEN THE USER CHECKED THE STENT AFTER THE PROCEDURE, THE PROXIMAL SIDE OF THE STENT EXPANDED.

    Description of Event or Problem · 0

    THE USER ADVANCED THE DELIVERY SYSTEM OVER A WIRE GUIDE AND RELEASED THE WHOLE STENT AT THE TARGET SITE IN THE ESOPHAGUS WITHOUT NOTABLE RESISTANCE, AND THEN HE REMOVED THE SAFETY WIRE. HOWEVER THE PROXIMAL SIDE OF THE STENT WOULD NOT EXPAND. HE ATTEMPTED TO EXPAND IT BY POKING WITH FORCEPS BUT IT STILL DIDN'T EXPAND. HE GRASPED THE STENT USING FORCEPS AND REMOVED FROM THE PATIENT AND SUCCESSFULLY PLACED EVO-20-25-12.5-E INSTEAD TO COMPLETE THE PROCEDURE. WHEN THE USER CHECKED THE STENT AFTER THE PROCEDURE, THE PROXIMAL SIDE OF THE STENT EXPANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764898 EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED ESW PROSTHESIS, ESOPHAGEAL ESW WILLIAM COOK EUROPE G48031 C1391911 10827002480312

    Patients

    Seq Age Sex Outcome Treatment
    1