FDA Adverse Event Injury Summary report: N

EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED

MDR report key: 7498271 · Received May 9, 2018

Report

Report Number: 3001845648-2018-00210
Event Type: Injury
Date Received: May 9, 2018
Date of Event: March 27, 2018
Report Date: August 2, 2018
Manufacturer: COOK IRELAND LTD
Product Code: FGE
UDI-DI: 10827002231280
PMA / PMN Number: K121430
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GB
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

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. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

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)(6). (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT: THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE: ¿DEVICE DID NOT DEPLOY PROPERLY AND NEEDED TO REMOVE WITH FORCEPS¿. DEVICE EVALUATION: THE EVO-10-11-6-B DEVICE OF LOT NUMBER C1425843 WAS RETURNED TO COOK IRELAND ON 31 JULY 2018 AND EVALUATED ON 01 AUG 2018. ADDITIONAL INFORMATION WAS ALSO REQUESTED (BETWEEN 12TH APRIL & 10 MAY 2018), HOWEVER WITH NO RESPONSE: 1. CAN WE GET THE FULL DETAILS OF THE FAULT THAT OCCURRED. 2. DID THE STENT FULLY/PARTIALLY DEPLOY? 3. DID THE PATIENT SUFFER ANY ADVERSE EFFECTS? 4. DID THEY REQUIRE ANY ADDITIONAL PROCEDURES? 5. HOW WAS THE PROCEDURE FINISHED? 6. ANY UPDATE ON THE DEVICE RETURN FOR THIS PR? COULD YOU PLEASE PROVIDE THE TRACKING NUMBER? LAB EVALUATION: UPON REVIEW OF THE RETURNED DEVICE, FILLER CANNULA WAS PROTRUDING 10 MM FROM PROXIMAL END OF HANDLE. COULD CHANGE WHEN ACTUATED. FILLER CANNULA TO HANDLE CANNULA WAS BROKEN AT GLUE JOINT. PROXIMAL END OF RETRIEVED LOOP CANNULA WAS BROKEN. THE SPECIFIC LOCATION OF DEFECTS ON THE DEVICE WAS AT THE FILLER CANNULA TO HANDLE CANNULA GLUE JOINT. THERE WAS DEFINITIVE EVIDENCE OF GLUE AT THE JOINT. NO LOCKWIRE WAS RETURNED. FULL ACTUATION WAS NOT POSSIBLE WHICH CONFIRMS THE COMPLAINT. A FUNCTIONAL CHECK WAS THE METHOD BY WHICH THE DEFECT WAS DETERMINED. HANDLE COMPONENT AND OUTER DISTAL FLEXOR OPERATED AS EXPECTED. HANDLE DISMANTLED AND FILLER CANNULA LENGTH MEASURED AT 1218 MM. THE FILLER CANNULA TO RETRIEVAL LOOP CANNULA JOINT WAS BROKEN BUT NOT KNOWN WHERE THIS WOULD HAVE OCCURRED. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ROOT CAUSE: A POSSIBLE ROOT CAUSE IS THAT INSUFFICIENT GLUE WAS APPLIED WHEN ASSEMBLING THE HANDLE CANNULA TO THE FILLER CANNULA. THERE WAS DEFINITE EVIDENCE OF GLUE AT THE JOINT OBSERVED DURING THE LAB EVALUATION OF THE RETURNED DEVICE. THERE WAS EVIDENCE OF GLUE AND IN-PROCESS DEPLOYMENT AND RE-CAPTURING OF THE DEVICE FUNCTIONALITY WOULD HAVE BEEN COMPLETED AT THE TIME OF MANUFACTURE. THEREFORE, IT CANNOT BE CONCLUSIVELY DETERMINED IF THIS ISSUE WAS MANUFACTURING RELATED. DOCUMENT REVIEW: WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-10-11-6-B OF LOT NUMBER C1425843 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL EVO-10-11-6-B 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. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1425843; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1425843. IFU REVIEW: AS PER THE INSTRUCTIONS FOR USE, NOTES SECTION THE USER IS INSTRUCTED OF THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". SUMMARY: THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE LAB EVALUATION. FULL ACTUATION WAS NOT POSSIBLE WHICH CONFIRMS THE COMPLAINT FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO REPORTED 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 INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). 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

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

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)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.