ZILVER 635 BILIARY SELF EXPANDING METAL STENT
Report
- Report Number
- 3001845648-2018-00452
- Event Type
- Malfunction
- Date Received
- September 26, 2018
- Date of Event
- August 21, 2018
- Report Date
- September 26, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002506241
- PMA / PMN Number
- K020788
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
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: 3005580113. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
510(K) NUMBER: K020788. (B)(4) (IMPORTER). EXEMPTION NUMBER: E2016031. IN IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PROBLEM STATEMENT: "THIS WAS THE RE-INTERVENTION CASE FOR THE PATIENT WHO PREVIOUSLY PLACED FOUR STENTS AT HEPATIC PORTAL REGION (THREE STENTS ON THE LEFT, ONE STENT ON THE RIGHT). ANOTHER STENT PLACEMENT FOR RIGHT BILE DUCT WAS TO BE PERFORMED. MTW CONTRAST TUBE PASSED THROUGH THE LESION, THEN, ZILBS-635-10-8 WAS ATTEMPTED TO ADVANCE. HOWEVER, THE DELIVERY SYSTEM WOULD NOT PASS THROUGH THE MESH OF THE STENT. DURING SEVERAL ATTEMPTS TO PASS THROUGH THE MESH, DISTAL STENT MARKER BECAME EXPOSED FROM THE DISTAL TIP OF THE SHEATH. IF THE SHEATH MOVES MORE THAN THIS POSITION, IT COULD LEAD TO STENT DEPLOYMENT AT UNINTENDED POSITION, THEREFORE THE USER STOPPED USING THE DEVICE." DEVICE EVALUATION: THE ZILBS-635-10-8 DEVICE OF LOT NUMBER C1512793 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM THE INFORMATION PROVIDED A METII-35-480-J WIRE GUIDE WAS USED WITH THE COMPLAINT DEVICE. IT IS UNKNOWN WHETHER A SPHINCTEROTOMY OR DILATION OF THE OBSTRUCTED AREA HAD BEEN PERFORMED PRIOR TO THIS OCCURRENCE. THE RIGHT BILE DUCT WAS THE INTENDED LOCATION FOR THE COMPLAINT DEVICE. AN OLYMPUS / JF-260 V ENDOSCOPE WAS USED DURING THE COMPLAINT PROCEDURE. IT IS UNKNOWN WHETHER OR NOT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE, STENT OR INTRODUCER THROUGH THE OBSTRUCTED AREA. IT WAS CONFIRMED THAT THE INTRODUCER WAS ADVANCED THROUGH THE SIDE (THROUGH THE MESH) OF A PREVIOUSLY PLACED STENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. QUESTIONS REGARDING THE REMOVAL OF THE WIRE GUIDE AFTER STENT DEPLOYMENT WERE ASKED BUT AS THESE WERE NOT APPLICABLE TO THE COMPLAINT THEY WERE NOT ANSWERED (THE STENT WAS NOT DEPLOYED). THE CUSTOMER PROVIDED IMAGES OF THE DEVICE BEFORE THE PROCEDURE AND AFTER THE ATTEMPTED ADVANCEMENT. THE IMAGES CLEARLY SHOW DAMAGE TO THE DISTAL WHITE TIP. IT IS POSSIBLE THAT THIS DAMAGE WAS THE RESULT OF SEVERAL ATTEMPTS TO ADVANCE THE INTRODUCER THROUGH THE MESH OF THE PREVIOUSLY PLACED STENT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. POSSIBLE ROOT CAUSES FOR THIS COMPLAINT COULD INCLUDE THE ADVANCEMENT OF THE INTRODUCER THROUGH THE SIDE OF A PREVIOUSLY PLACED STENT (OFF LABEL USE). IT IS POSSIBLE THAT RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO ADVANCE THE INTRODUCER THROUGH THE PREVIOUSLY PLACED STENT. IT IS POSSIBLE THAT RESISTANCE DURING ADVANCEMENT CAUSED OR CONTRIBUTED TO ADDITIONAL HIGH FORCE BEING APPLIED ON THE FLEXOR CAUSING THE DISTAL END OF THE STENT TO BECOME EXPOSED. HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR EVALUATION AND AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT CAN BE NOTED THAT THE INSTRUCTIONS FOR USE AND THE JAPANESE PACKAGING INSERT STATES THE FOLLOWING; ¿THIS DEVICE IS NOT INTENDED TO BE DEPLOYED THROUGH THE WALL OF A PREVIOUSLY PLACED OR EXISTING METAL STENT. DOING SO COULD MAKE IT DIFFICULT OR IMPOSSIBLE TO REMOVE THE DELIVERY SYSTEM.¿ IT MAY BE NOTED THAT A PROJECT (IRE0108) HAS BEEN COMPLETED AND ADDRESSES THE ISSUE OF PREMATURE DEPLOYMENT DUE TO INSUFFICIENT FLEXOR STRENGTH WITH THE SAFETY TAB IN PLACE. 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 (C1512793) 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 C1512793. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS INCIDENT DID NOT OCCUR. THEREFORE, THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE RISK WAS DETERMINED TO BE LOW (CATEGORY III). 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.
THIS WAS THE RE-INTERVENTION CASE FOR THE PATIENT WHO PREVIOUSLY PLACED FOUR STENTS AT HEPATIC PORTAL REGION (THREE STENTS ON THE LEFT, ONE STENT ON THE RIGHT). ANOTHER STENT PLACEMENT FOR RIGHT BILE DUCT WAS TO BE PERFORMED. MTW CONTRAST TUBE PASSED THROUGH THE LESION, THEN, ZILBS-635-10-8 WAS ATTEMPTED TO ADVANCE. HOWEVER, THE DELIVERY SYSTEM WOULD NOT PASS THROUGH THE MESH OF THE STENT. DURING SEVERAL ATTEMPTS TO PASS THROUGH THE MESH, DISTAL STENT MARKER BECAME EXPOSED FROM THE DISTAL TIP OF THE SHEATH. IF THE SHEATH MOVES MORE THAN THIS POSITION, IT COULD LEAD TO STENT DEPLOYMENT AT UNINTENDED POSITION, THEREFORE THE USER STOPPED USING THE DEVICE. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿PREMATURE STENT DEPLOYMENT WITH SAFETY LOCK IN PLACE
THIS WAS THE RE-INTERVENTION CASE FOR THE PATIENT WHO PREVIOUSLY PLACED FOUR STENTS AT HEPATIC PORTAL REGION (THREE STENTS ON THE LEFT, ONE STENT ON THE RIGHT). ANOTHER STENT PLACEMENT FOR RIGHT BILE DUCT WAS TO BE PERFORMED. MTW CONTRAST TUBE PASSED THROUGH THE LESION, THEN, ZILBS-635-10-8 WAS ATTEMPTED TO ADVANCE. HOWEVER, THE DELIVERY SYSTEM WOULD NOT PASS THROUGH THE MESH OF THE STENT. DURING SEVERAL ATTEMPTS TO PASS THROUGH THE MESH, DISTAL STENT MARKER BECAME EXPOSED FROM THE DISTAL TIP OF THE SHEATH. IF THE SHEATH MOVES MORE THAN THIS POSITION, IT COULD LEAD TO STENT DEPLOYMENT AT UNINTENDED POSITION, THEREFORE THE USER STOPPED USING THE DEVICE. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿PREMATURE STENT DEPLOYMENT WITH SAFETY LOCK IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 749697 | ZILVER 635 BILIARY SELF EXPANDING METAL STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | G50624 | C1512793 | 10827002506241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |