EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
Report
- Report Number
- 3001845648-2018-00455
- Event Type
- Injury
- Date Received
- September 27, 2018
- Date of Event
- August 31, 2018
- Report Date
- September 27, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- ESW
- UDI-DI
- 10827002480305
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
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.
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. ADDITIONAL INFORMATION: PREFIX: EVO GENERAL QUESTIONS: 1. AT WHAT STAGE OF THE PROCEDURE DID THE COMPLAINT OCCUR?(WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL) (WHILE REMOVING THE INTRODUCER) 2. WHAT ENDOSCOPE TYPE AND CHANNEL SIZE WAS USED? ENDOSCOPE IS NOT USED FOR THE ESOPHAGUS STENT PLACEMENT 3. WHAT WAS THE POSITION OF THE ELEVATOR? WAS IT OPENED OR CLOSED? ENDOSCOPE IS NOT USED FOR THE ESOPHAGUS STENT PLACEMENT 4. DETAILS OF THE WIRE GUIDE USED (DIAMETER, TYPE, MAKE)? JAG WIRE(035INCH) 5. DID ANY PART OF THE STENT CONTACT THE PATIENT¿S ANATOMY WHEN THE COMPLAINT OCCURRED? (YES) 6. HOW LONG WAS THE STENT IN THE PATIENT BY THE TIME THIS COMPLAINT OCCURRED? N/A 7. FOR DEVICES WHERE THE IFU STATES FOR LONGER TERM PATENCY HAS NOT BEEN ESTABLISHED, WAS PERIODIC EVALUATION COMPLETE AND HOW OFTEN? N/A STRICTURE INFORMATION: 1. WHAT WAS THE LENGTH AND DIAMETER OF THE STRICTURE? LENGTH 20MM DIAMETER 20MM 2. WHERE WAS THE STRICTURE LOCATED IN THE BODY? CARDIAC PORTION OF THE ESOPHAGUS 3. WAS THERE RESISTANCE FELT PASSING WIRE GUIDE THROUGH STRICTURE? (NO) 4. WAS THERE RESISTANCE FELT PASSING THE EVOLUTION THROUGH STRICTURE? (NO) 5. WAS THE STRICTURE DILATED BEFORE STENT PLACEMENT? (NO) QUESTIONS RELATED TO DURING INSERTION INTO PATIENT: 1. WAS THE PRODUCT INSPECTED FOR KINKS OR DAMAGE BEFORE USE? (NO) 2A. WAS RESISTANCE FELT DURING INSERTION INTO PATIENT? (NO) 2B. IF YES, AT WHAT POINT? N/A QUESTIONS RELATED TO DURING STENT PLACEMENT: 1. DID THE PRODUCT FAIL DURING STENT DEPLOYMENT OR RECAPTURE? (NO) 2. WAS THE DIRECTIONAL BUTTON PRESSED DURING USE? (YES) 3. WAS THE YELLOW MARKER KEPT IN VIEW DURING DEPLOYMENT? ENDOSCOPE IS NOT USED FOR THE ESOPHAGUS STENT PLACEMENT 4. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? (NO) QUESTIONS RELATED TO DURING INTRODUCER WITHDRAWAL: 1A. WAS FINAL STENT PLACEMENT CONFIRMED USING ENDOSCOPY / FLUOROSCOPY? (YES) 1B. IF YES, WHAT WAS USED? FLUOROSCOPIC IMAGE 2. DID THE STENT OPEN SUFFICIENTLY TO ALLOW WITHDRAWAL OF INTRODUCER SAFELY? IT SEEMS THERE WAS NO PROBLEM BASED ON THE FLUOROSCOPIC IMAGE 3. WAS THE SAFETY WIRE FULLY REMOVED BEFORE REMOVING THE DELIVERY SYSTEM? (YES) 4. DID ANY PART OF THE PRODUCT SNAG/GET CAUGHT WITH THE STENT WHEN REMOVING THE DELIVERY SYSTEM? ¿¿(YES) 5. ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? (NO) QUESTIONS RELATED TO DURING STENT REPOSITIONING/REMOVAL: 1. WHAT INSTRUMENT WAS USED FOR STENT REPOSITIONING / REMOVAL? FORCEPS, SNARE¿ ¿¿(FORCEPS) 2. WAS THE LASSO (SUTURE) LOOP USED DURING REPOSITIONING / REMOVAL? (YES) THE EVO-20-25-8-E DEVICE OF LOT NUMBER C1407823 WAS NOT RETURNED TO COOK IRELAND. AS THE DEVICE WAS NOT RETURNED A DOCUMENT BASED EVALUATION WAS CARRIED OUT. A POSSIBLE ROOT CAUSE FOR THIS COMPLAINT IS THE USER'S INTERACTION WITH THE DEVICE/USER ERROR. AS PER INSTRUCTIONS FOR USE, "AFTER DEPLOYMENT, FLUOROSCOPICALLY CONFIRM FULL STENT EXPANSION. ONCE FULL EXPANSION IS CONFIRMED, INTRODUCTION SYSTEM CAN BE SAFELY REMOVED. " THE CUSTOMER MAY NOT HAVE COMPLETED THIS STEP IN THE IFU0061-5, THEREFORE A POTENTIAL ROOT CAUSE IS USER ERROR. ANOTHER POSSIBLE ROOT CAUSE FOR THIS COMPLAINT IS THE STRICTURE ON THE PATIENT¿S ANATOMY. THE STRICTURE MAY HAVE INTERFERED WITH THE CORRECT STENT PLACEMENT, THEREFORE LEADING TO THE TIP OF THE DELIVERY SYSTEM GETTING STUCK AT DISTAL SIDE OF THE STENT. 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 C1407823. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER C1407823. SUMMARY: AS THE DEVICE WAS NOT RETURNED THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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.
ESOPHAGUS STENT PLACEMENT WAS PERFORMED TO THE PATIENT WHO HAD CARDIAC PORTION OF THE ESOPHAGUS STENOSIS DUE TO STOMACH CANCER INVASION. AFTER STENT PLACEMENT, THE USER ATTEMPTED TO WITHDRAW THE DELIVERY SYSTEM FROM THE PATIENT'S BODY, HOWEVER THE TIP OF THE DELIVERY SYSTEM GOT STUCK AT DISTAL SIDE OF THE STENT, THEN, THE STENT MIGRATED AND PLACED MORE PROXIMAL SIDE WHERE HAS NOT BEEN COVERED STENOSED LESION. TO RETRIEVE THE STENT, ENDOSCOPY WAS INSERTED AND LASSO WAS GRABBED WITH SNARE. AFTER WITHDRAW THE STENT INTO ENDOSCOPY, STENT AND ENDOSCOPY WERE REMOVED TOGETHER. ANOTHER STENT OF THE SAME RPN WAS PLACED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.
ESOPHAGUS STENT PLACEMENT WAS PERFORMED TO THE PATIENT WHO HAD CARDIAC PORTION OF THE ESOPHAGUS STENOSIS DUE TO STOMACH CANCER INVASION. AFTER STENT PLACEMENT, THE USER ATTEMPTED TO WITHDRAW THE DELIVERY SYSTEM FROM THE PATIENT'S BODY, HOWEVER THE TIP OF THE DELIVERY SYSTEM GOT STUCK AT DISTAL SIDE OF THE STENT, THEN, THE STENT MIGRATED AND PLACED MORE PROXIMAL SIDE WHERE HAS NOT BEEN COVERED STENOSED LESION. TO RETRIEVE THE STENT, ENDOSCOPY WAS INSERTED AND LASSO WAS GRABBED WITH SNARE. AFTER WITHDRAW THE STENT INTO ENDOSCOPY, STENT AND ENDOSCOPY WERE REMOVED TOGETHER. ANOTHER STENT OF THE SAME RPN WAS PLACED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 756337 | EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED | ESW PROSTHESIS, ESOPHAGEAL | ESW | COOK IRELAND LTD | G48030 | C1407823 | 10827002480305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |