ZILVER 635 SELF-EXPANDING BILIARY STENT
Report
- Report Number
- 3001845648-2017-00217
- Event Type
- Injury
- Date Received
- June 9, 2017
- Date of Event
- May 3, 2017
- Report Date
- June 7, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
THIS SPECIFIC ZILVER DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENT/SETS (ZILVER) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K) # K040505 / K163169. 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 THE ZIB6-40-9-8.0 DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. IMAGES OF THE IMPLANTED STENT WERE PROVIDED. THE INVESTIGATION WILL BE UPDATED ONCE THE IMAGES HAVE BEEN REVIEWED BY A CLINICAL SPECIALIST. ANY RELATION BETWEEN THE STENT FRACTURE AND BLOCKAGE WILL BE ASSESSED DURING THE IMAGE REVIEW. THERE IS NO EVIDENCE TO SUGGEST THIS EVENT DID NOT OCCUR. THEREFORE, THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. THE DEVICE RELATED THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION, THE IMAGES HAVE NOT YET BEEN REVIEWED, AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE FAILURE MODE OR ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER 635 BILIARY DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A WALL STENT WAS PLACED INSIDE THE FRACTURED STENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
STENT PLACED IN SEPTEMBER, BLOCKED AND THE FOUND TO BE FRACTURED. AS PER CC FORM: " THE STENT WAS BLOCKED 6 MONTHS POST INSERTION - ON ACCESSING TO PLACE ANOTHER STENT IT WAS FOUND TO BE FRACTURED."
THIS SPECIFIC ZILVER DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENT/SETS (ZILVER) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K) # K040505 / K163169. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THE (B)(4) DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: 1. TWO IMAGES PERFORMED AT THE SECONDARY INTERVENTION ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE FIRST WAS AN IMAGE AFTER THE PERCUTANEOUS CHOLANGIOGRAPHY. CONTRAST FROM A NEEDLE IN THE LEFT BILIARY OPACIFIED A DILATED, BUT ILL -DEFINED LEFT BILIARY DUCT. THE ILL DEFINITION WAS CONSISTENT WITH TUMOR AND LIKELY INSPISSATED BILE. PARTIALLY OCCLUDED, BETTER DEFINED, NON-DILATED DUCTS WERE VISIBLE CLOSER TO THE EXPECTED LOCATION OF THE RIGHT AND LEFT DUCT CONFLUENCE. THE RIGHT AND LEFT DUCT CONFLUENCE AND COMMON HEPATIC AND COMMON BILE DUCTS WERE OCCLUDED EXCEPT FOR A TINY UNSEEN CHANNEL THAT MUST BE PRESENT BASED ON FILLING OF A SINGLE RIGHT INFERIOR BILIARY DUCT BRANCH. 3. THE PREVIOUSLY IMPLANTED STENT WAS TRANSVERSELY FRACTURED NEAR THE CENTER IN TYPE IV OR V FASHION. DETAIL IS INSUFFICIENT TO DISTINGUISH BETWEEN A TYPE IV OR V FRACTURE. NO ELONGATION WAS PRESENT. 4. THE SECOND IMAGE DEMONSTRATES WIRE CANNULATION OF THE OCCLUDED BILIARY DUCT CONFLUENCE, COMMON HEPATIC DUCT AND STENTED COMMON BILE DUCT. A SECOND, YET TO BE DEPLOYED STENT HAD BEEN INTRODUCED TO NEAR THE ZILVER STENT, DISTAL END. THIS STENT WAS MUCH LONGER THAN THE ZILVER STENT AND EXTENDED TO THE PERIPHERAL LEFT DUCTS, JUST DEEP TO THE LEFT BILIARY DUCT PUNCTURE SITE. 5. DILATED RIGHT AND LEFT BILIARY DUCTS, HEPATIC DUCT CONFLUENCE, AND PROXIMAL COMMON HEPATIC DUCT WERE NOW FAINTLY OPACIFIED WITH CONTRAST. 6. THE LOCATION OF THE FRACTURE WAS AT OR JUST PROXIMAL TO THE AMPULLA OF VATER BASED ON THE WIRE'S PATH MARKING THE FOURTH PORTION OF THE DUODENUM AND THE FRACTURE'S POSITION RELATIVE TO THE SPINE. AT LEAST 34MM OF STENT LIKELY EXTENDED INTO THE DUODENUM. IMPRESSION: 1. STENT FRACTURE LIKELY JUST PROXIMAL TO, AND AT THE AMPULLA OF VATER IS CONFIRMED. THE STENT LIKELY FRACTURED FROM THE REPETITIVE STRESS OF PERISTALSIS ON THE 34MM LONG PORTION PROJECTING INTO THE DUODENUM. 2. ALTHOUGH THE FRACTURE MAY HAVE CONTRIBUTED TO STENT AND COMMON BILE DUCT OCCLUSION, NEW TUMOR WITHIN THE BILE DUCTS WAS LIKELY, GIVEN THE LEFT MAIN DUCT INITIAL APPEARANCE AND THE VERY LONG SECOND STENT INTENDED TO COVER THE LEFT MAIN DUCT THROUGH THE ZILVER STENT. 3. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. 4. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. LEFT MAIN DUCT TUMOR AND RIGHT DUCT BRANCH TUMORS WERE OBSERVED. GIVEN THE LENGTH OF THE NEW STENT, THE LEFT MAIN DUCT TUMOR WAS LIKELY NEW. 5. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE ZILVER STENT HAD BEEN IMPLANTED PROJECTING 34MM BEYOND THE AMPULLA INTO THE DUODENUM. 6. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE STENT FRACTURED JUST PROXIMAL TO, AND AT THE AMPULLA. 7. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. THE CUSTOMER COMPLAINT IS CONFIRMED AS STENT FRACTURE WAS OBSERVED IN THE IMAGE REVIEW. PRODUCT DEVELOPMENT ENGINEERS RESPONDED TO THE IMAGE REVIEW: "THE STENT WAS PLACED CORRECTLY AT 34MM INTO THE DUODENUM. WE SPECIFY APPROX. 5MM IN THE IFU AS IF IT IS PLACED TOO FAR INTO THE DUCT IT WILL IMPACT ON THE DUODENAL WALL AND ALSO POTENTIALLY INHIBIT THE PASSAGE OF FOOD. READING THE COMPLAINT IT APPEARS THAT THE FRACTURED STENT WAS IN A DIFFERENT AREA THAN THE OCCLUSION WHICH IS WHAT THE ADVERSE EVENT REPORTED WAS SO I¿M GUESSING THAT THE PATIENT HAD NOT REPORTED ADVERSE EVENTS ASSOCIATED WITH THE FRACTURE. THE PATIENTS TUMOUR HAD GROWN INTO THE STENT AGAIN AND THAT IS SOMETHING THAT IS KNOWN TO OCCUR WITH UNCOVERED STENTS SO THERE WAS NO ACTUAL DEFECT WITH THE STENT IN THE OCCLUDED REGION AS FAR AS I CAN SEE. THE IFU DOES INDICATE THAT TUMOURS CAN GROW THROUGH THE STENTS SO I DON¿T BELIEVE ANY IFU UPDATES ARE REQUIRED." ACCORDING TO THE IMAGE REVIEW, THE STENT COULD HAVE FRACTURED FROM THE REPETITIVE STRESS OF PERISTALSIS ON THE 34MM LONG PORTION PROJECTING INTO THE DUODENUM. THE STENT FRACTURE AND/OR THE DISEASE STATE MAY HAVE CAUSED OR CONTRIBUTED TO STENT AND COMMON BILE DUCT OCCLUSION. THE DEVICE RELATED THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION, AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. AS PER THE PRODUCT INSTRUCTION FOR USE: "THE STENT HAS NOT BEEN DESIGNED TO INHIBIT TUMOR INGROWTH. TISSUE MAY GROW THROUGH STENTS." "STENTS BRIDGING THE PAPILLA SHOULD EXTENDED APPROXIMATELY 5 MM BEYOND THE PAPILLA AND INTO THE DUODENUM AFTER DEPLOYMENT." AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER 635 BILIARY DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A WALL STENT WAS PLACED INSIDE THE FRACTURED STENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS. THIS SPECIFIC ZILVER DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENT/SETS (ZILVER) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K) # K040505 / K163169. (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THE (B)(4) DEVICE OF UNKNOWN LOT NUMBER INVOLVED IN THIS COMPLAINT WAS IMPLANTED IN THE PATIENT, AND WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: FINDINGS: 1. TWO IMAGES PERFORMED AT THE SECONDARY INTERVENTION ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE FIRST WAS AN IMAGE AFTER THE PERCUTANEOUS CHOLANGIOGRAPHY. CONTRAST FROM A NEEDLE IN THE LEFT BILIARY OPACIFIED A DILATED, BUT ILL -DEFINED LEFT BILIARY DUCT. THE ILL DEFINITION WAS CONSISTENT WITH TUMOR AND LIKELY INSPISSATED BILE. PARTIALLY OCCLUDED, BETTER DEFINED, NON-DILATED DUCTS WERE VISIBLE CLOSER TO THE EXPECTED LOCATION OF THE RIGHT AND LEFT DUCT CONFLUENCE. THE RIGHT AND LEFT DUCT CONFLUENCE AND COMMON HEPATIC AND COMMON BILE DUCTS WERE OCCLUDED EXCEPT FOR A TINY UNSEEN CHANNEL THAT MUST BE PRESENT BASED ON FILLING OF A SINGLE RIGHT INFERIOR BILIARY DUCT BRANCH. 3. THE PREVIOUSLY IMPLANTED STENT WAS TRANSVERSELY FRACTURED NEAR THE CENTER IN TYPE IV OR V FASHION. DETAIL IS INSUFFICIENT TO DISTINGUISH BETWEEN A TYPE IV OR V FRACTURE. NO ELONGATION WAS PRESENT. 4. THE SECOND IMAGE DEMONSTRATES WIRE CANNULATION OF THE OCCLUDED BILIARY DUCT CONFLUENCE, COMMON HEPATIC DUCT AND STENTED COMMON BILE DUCT. A SECOND, YET TO BE DEPLOYED STENT HAD BEEN INTRODUCED TO NEAR THE ZILVER STENT, DISTAL END. THIS STENT WAS MUCH LONGER THAN THE ZILVER STENT AND EXTENDED TO THE PERIPHERAL LEFT DUCTS, JUST DEEP TO THE LEFT BILIARY DUCT PUNCTURE SITE. 5. DILATED RIGHT AND LEFT BILIARY DUCTS, HEPATIC DUCT CONFLUENCE, AND PROXIMAL COMMON HEPATIC DUCT WERE NOW FAINTLY OPACIFIED WITH CONTRAST. 6. THE LOCATION OF THE FRACTURE WAS AT OR JUST PROXIMAL TO THE AMPULLA OF VATER BASED ON THE WIRE'S PATH MARKING THE FOURTH PORTION OF THE DUODENUM AND THE FRACTURE'S POSITION RELATIVE TO THE SPINE. AT LEAST 34MM OF STENT LIKELY EXTENDED INTO THE DUODENUM. IMPRESSION: 1. STENT FRACTURE LIKELY JUST PROXIMAL TO, AND AT THE AMPULLA OF VATER IS CONFIRMED. THE STENT LIKELY FRACTURED FROM THE REPETITIVE STRESS OF PERISTALSIS ON THE 34MM LONG PORTION PROJECTING INTO THE DUODENUM. 2. ALTHOUGH THE FRACTURE MAY HAVE CONTRIBUTED TO STENT AND COMMON BILE DUCT OCCLUSION, NEW TUMOR WITHIN THE BILE DUCTS WAS LIKELY, GIVEN THE LEFT MAIN DUCT INITIAL APPEARANCE AND THE VERY LONG SECOND STENT INTENDED TO COVER THE LEFT MAIN DUCT THROUGH THE ZILVER STENT. 3. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT'S ANATOMY WERE NOT OBSERVED. 4. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE OBSERVED. LEFT MAIN DUCT TUMOR AND RIGHT DUCT BRANCH TUMORS WERE OBSERVED. GIVEN THE LENGTH OF THE NEW STENT, THE LEFT MAIN DUCT TUMOR WAS LIKELY NEW. 5. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE ZILVER STENT HAD BEEN IMPLANTED PROJECTING 34MM BEYOND THE AMPULLA INTO THE DUODENUM. 6. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE OBSERVED. THE STENT FRACTURED JUST PROXIMAL TO, AND AT THE AMPULLA. 7. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. THE CUSTOMER COMPLAINT IS CONFIRMED AS STENT FRACTURE WAS OBSERVED IN THE IMAGE REVIEW. PRODUCT DEVELOPMENT ENGINEERS RESPONDED TO THE IMAGE REVIEW: "THE STENT WAS PLACED CORRECTLY AT 34MM INTO THE DUODENUM. WE SPECIFY APPROX. 5MM IN THE IFU AS IF IT IS PLACED TOO FAR INTO THE DUCT IT WILL IMPACT ON THE DUODENAL WALL AND ALSO POTENTIALLY INHIBIT THE PASSAGE OF FOOD. READING THE COMPLAINT IT APPEARS THAT THE FRACTURED STENT WAS IN A DIFFERENT AREA THAN THE OCCLUSION WHICH IS WHAT THE ADVERSE EVENT REPORTED WAS SO I¿M GUESSING THAT THE PATIENT HAD NOT REPORTED ADVERSE EVENTS ASSOCIATED WITH THE FRACTURE. THE PATIENTS TUMOUR HAD GROWN INTO THE STENT AGAIN AND THAT IS SOMETHING THAT IS KNOWN TO OCCUR WITH UNCOVERED STENTS SO THERE WAS NO ACTUAL DEFECT WITH THE STENT IN THE OCCLUDED REGION AS FAR AS I CAN SEE. THE IFU DOES INDICATE THAT TUMOURS CAN GROW THROUGH THE STENTS SO I DON¿T BELIEVE ANY IFU UPDATES ARE REQUIRED." ACCORDING TO THE IMAGE REVIEW, THE STENT COULD HAVE FRACTURED FROM THE REPETITIVE STRESS OF PERISTALSIS ON THE 34MM LONG PORTION PROJECTING INTO THE DUODENUM. THE STENT FRACTURE AND/OR THE DISEASE STATE MAY HAVE CAUSED OR CONTRIBUTED TO STENT AND COMMON BILE DUCT OCCLUSION. THE DEVICE RELATED THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION, AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT. THEREFORE, A DEFINITIVE ROOT CAUSE FOR THIS OCCURRENCE CANNOT BE DETERMINED. AS PER THE PRODUCT INSTRUCTION FOR USE: "THE STENT HAS NOT BEEN DESIGNED TO INHIBIT TUMOR INGROWTH. TISSUE MAY GROW THROUGH STENTS." "STENTS BRIDGING THE PAPILLA SHOULD EXTENDED APPROXIMATELY 5 MM BEYOND THE PAPILLA AND INTO THE DUODENUM AFTER DEPLOYMENT." AS THE LOT NUMBER OF THE COMPLAINT STENT IS UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL ZILVER 635 BILIARY DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A WALL STENT WAS PLACED INSIDE THE FRACTURED STENT. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE IMAGE REVIEW STENT PLACED IN SEPTEMBER , BLOCKED AND THE FOUND TO BE FRACTURED. AS PER CC FORM: " THE STENT WAS BLOCKED 6 MONTHS POST INSERTION - ON ACCESSING TO PLACE ANOTHER STENT IT WAS FOUND TO BE FRACTURED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410638 | ZILVER 635 SELF-EXPANDING BILIARY STENT | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |