ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2018-00357
- Event Type
- Malfunction
- Date Received
- August 2, 2018
- Date of Event
- July 3, 2018
- Report Date
- February 17, 2020
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002506210
- PMA / PMN Number
- K020788
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
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. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
510(K) NUMBER: K020788. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510(K) NUMBER: K020788. 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 DEVICE WAS USED ON A PATIENT WHO HAD UNDERGONE BILROTH II GASTRECTOMY BEFORE. THE DELIVERY SYSTEM OF THE DEVICE WAS ADVANCED TO THE TARGET SITE IN THE COMMON BILE DUCT. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, HE ENCOUNTERED STRONG RESISTANCE, BUT CONTINUED DEPLOYMENT. THEN, THE SHEATH BROKE WHICH MADE IT IMPOSSIBLE TO DEPLOY THE STENT. THEREFORE, ANOTHER MANUFACTURER'S STENT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED." DEVICE EVALUATION: THE ZILBS-635-10-6 DEVICE OF LOT NUMBER C1488743 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. A VISIGLUIDE WIRE GUIDE OF UNKNOWN DIAMETER WAS USED WITH THE DEVICE. A SPHINCTEROTOMY WAS NOT PERFORMED PRIOR TO THIS EVENT. PRE-DILATION WAS NOT PERFORMED PRIOR TO THE EVENT. THE STENT WAS INTENDED FOR USE IN THE COMMON BILE DUCT. RESISTANCE WAS NOT FELT DURING ADVANCEMENT BUT WAS FELT DURING DEPLOYMENT. NO SECTION OF THE DEVICE DETACHED INSIDE THE PATIENT. ANOTHER MANUFACTURER¿S STENT WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 09 AUGUST 2018. ON EVALUATION OF THE RETURNED DEVICE, THERE WAS MINOR DAMAGE ON THE FLEXOR. A 7.0 MM CUT WAS NOTED ON THE DISTAL FLEXOR AND THE FLEXOR HAD SEPARATED 27.3 CM FROM THE DISTAL END OF THE FLEXOR. THE FLEXOR LENGTH WAS MEASURED AT 200.4 CM WHICH WAS WITHIN SPECIFICATION OF 200 + 0.6 CM. THE RED SAFETY TRIGGER WAS NOT RETURNED WITH THE DEVICE BUT THE STENT WAS STILL LOADED. A GAP BETWEEN THE STENT AND THE PUSHER RING SUGGESTED DEPLOYMENT HAD BEEN ATTEMPTED. COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE FLEXOR WAS SEPARATED. POSSIBLE ROOT CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE USE OF THE DEVICE IN A PATIENT WHO HAD ALTERED ANATOMY (AFTER A BILROTH II GASTRECTOMY). THIS IS CONSIDERED NON-STANDARD ERCP PROCEDURE - USER ERROR. THE USE OF THE DEVICE IN A NON-STANDARD ERCP PROCEDURE COULD HAVE CAUSED OR CONTRIBUTED TO DAMAGE ON THE DISTAL FLEXOR. THE DAMAGE TO THE FLEXOR COULD HAVE CAUSED OR CONTRIBUTED TO RESISTANCE DURING DEPLOYMENT RESULTING IN SEPARATION OF THE FLEXOR. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: ¿THIS DEVICE IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN BILIARY STENTING. STANDARD ERCP TECHNIQUES FOR PLACEMENT OF BILIARY METAL STENTS SHOULD BE EMPLOYED.¿ IT MAY BE NOTED THAT PROJECT (B)(4) HAS BEEN COMPLETED AND ADDRESSES THE ISSUE OF OUTER SHEATH SEPARATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILBS-635 DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (B)(4) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1488743. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. THE FLEXOR WAS SEPARATED. THE RISK WAS DETERMINED TO BE RISK CATEGORY III /NO RISK. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
DEVICE EVALUATION: THE ZILBS-635-10-6 DEVICE OF LOT NUMBER C1488743 INVOLVED IN THIS COMPLAINT WAS RETURNED FOR EVALUATION, WITH THE ORIGINAL PACKAGING. THE PACKAGING WAS OPEN ON RECEIPT. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 09 AUGUST 2018. REFER TO ATTACHMENTS F1426A AND F1426B FOR LAB ATTENDANCE AND NOTES. ON EVALUATION OF THE RETURNED DEVICE, THERE WAS MINOR DAMAGE ON THE FLEXOR. A 7.0 MM CUT WAS NOTED ON THE DISTAL FLEXOR AND THE FLEXOR HAD SEPARATED 27.3 CM FROM THE DISTAL END OF THE FLEXOR. THE FLEXOR LENGTH WAS MEASURED AT 200.4 CM WHICH WAS WITHIN SPECIFICATION OF 200 + 0.6 CM (REF. DWG1690). THE RED SAFETY TRIGGER WAS NOT RETURNED WITH THE DEVICE BUT THE STENT WAS STILL LOADED. A GAP BETWEEN THE STENT AND THE PUSHER RING SUGGESTED DEPLOYMENT HAD BEEN ATTEMPTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ZILBS-635-10-6 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 MANUFACTURING RECORDS FOR ZILBS-635-10-6 OF LOT NUMBER C1488743 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1488743. THE INSTRUCTIONS FOR USE (IFU0065-3) STATES THE FOLLOWING: ¿THIS DEVICE IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN BILIARY STENTING. STANDARD ERCP TECHNIQUES FOR PLACEMENT OF BILIARY METAL STENTS SHOULD BE EMPLOYED.¿ ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO USE OF THE DEVICE IN A PATIENT WITH ALTERED ANATOMY. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE DEVICE WAS USED IN A PATIENT WHO HAD UNDERGONE BILROTH II GASTRECTOMY. IT IS ALSO KNOWN THAT THE PHYSICIAN ENCOUNTERED RESISTANCE DURING DEPLOYMENT. USE OF THE DEVICE IN A MANNER OTHER THAN INTENDED WITHIN THE IFU MAY HAVE RESULTED IN THE DAMAGE OBSERVED ON THE OUTER SHEATH OUT THE DEVICE. THIS DAMAGE, COMBINED WITH THE OFF-LABEL USE OF THE DEVICE, MAY HAVE CONTRIBUTED TO THE RESISTANCE FELT BY THE PHYSICIAN DURING ATTEMPTED DEPLOYMENT RESULTING IN SEPARATION OF THE OUTER SHEATH. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE LABORATORY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
REPORT IS BEING SUBMITTED UNDER THE PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR BREAKING DURING DEPLOYMENT¿. THE DEVICE WAS USED ON A PATIENT WHO HAD UNDERGONE BILROTH II GASTRECTOMY BEFORE. THE DELIVERY SYSTEM OF THE DEVICE WAS ADVANCED TO THE TARGET SITE IN THE COMMON BILE DUCT. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, HE ENCOUNTERED STRONG RESISTANCE, BUT CONTINUED DEPLOYMENT. THEN, THE SHEATH BROKE WHICH MADE IT IMPOSSIBLE TO DEPLOY THE STENT. THEREFORE, ANOTHER MANUFACTURER'S STENT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
THE DEVICE WAS USED ON A PATIENT WHO HAD UNDERGONE BILROTH II GASTRECTOMY BEFORE. THE DELIVERY SYSTEM OF THE DEVICE WAS ADVANCED TO THE TARGET SITE IN THE COMMON BILE DUCT. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, HE ENCOUNTERED STRONG RESISTANCE, BUT CONTINUED DEPLOYMENT. THEN, THE SHEATH BROKE WHICH MADE IT IMPOSSIBLE TO DEPLOY THE STENT. THEREFORE, ANOTHER MANUFACTURER'S STENT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
THE DEVICE WAS USED ON A PATIENT WHO HAD UNDERGONE BILROTH II GASTRECTOMY BEFORE. THE DELIVERY SYSTEM OF THE DEVICE WAS ADVANCED TO THE TARGET SITE IN THE COMMON BILE DUCT. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, HE ENCOUNTERED STRONG RESISTANCE, BUT CONTINUED DEPLOYMENT. THEN, THE SHEATH BROKE WHICH MADE IT IMPOSSIBLE TO DEPLOY THE STENT. THEREFORE, ANOTHER MANUFACTURER'S STENT WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.
ADDITIONAL INFORMATION RECEIVED: PHYSICIAN'S COMMENT: THE POSITION WAS AS DIFFICULT AS ENDOSCOPE WAS TIGHTLY ANGLED. HOWEVER, ANOTHER MANUFACTURER'S STENT COULD BE PLACED THOUGH RESISTANCE WAS FELT DURING DEPLOYMENT TOO, I CANNOT DETERMINE IF THE CAUSE WAS RELATED TO AN ANGLE OF THE ENDOSCOPE OR NOT. ADDITIONAL INFORMATION: FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 1. WHAT IS THE REORDER NUMBER OF THE WIRE GUIDE USED WITH THIS DEVICE? VISIGLIDE. 2. HAD A SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE? NO. 3. HAD DILATION OF THE OBSTRUCTED AREA BEEN PERFORMED PRIOR TO THIS OCCURRENCE? NO. 4. WHAT IS THE ENDOSCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? UNKNOWN FUJIFILM/ EN-580T (PROVIDED ON 24/JUL/2018, (B)(6) ). 5. PLEASE DESCRIBE THE LOCATION IN THE BODY WHERE THE STENT WAS TO BE PLACED. COMMON BILE DUCT. 6. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE OBSTRUCTED AREA? NO. 7. WAS RESISTANCE ENCOUNTERED WHEN ADVANCING THE STENT AND INTRODUCER THROUGH THE OBSTRUCTED AREA? NO. 8. WAS THE INTRODUCER ADVANCED THROUGH THE SIDE OF A PREVIOUSLY PLACED STENT? NO. 9. PLEASE ESTIMATE AMOUNT OF TIME THE STENT WAS IN PLACE PRIOR TO THIS OCCURRENCE. N/A. 10. DID ANY SECTION OF THE DEVICE DETACH INSIDE THE ENDOSCOPE OR PATIENT? NO. 11. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? ANOTHER MANUFACTURER'S STENT WAS USED INSTEAD TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586542 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | G50621 | C1488743 | 10827002506210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |