ZILVER 635 SELF-EXPANDING BILIARY STENT
Report
- Report Number
- 3001845648-2018-00090
- Event Type
- Injury
- Date Received
- February 28, 2018
- Report Date
- March 27, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002372778
- Report Source
- Manufacturer report
- Reporter Location
- GB
- 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. PMA/510(K) # K051124 / K163169. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.
(B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PMA/510(K) # K051124 / K163169. THIS FOLLOW UP MDR IS BEING SUBMITTED AS THE INVESTIGATION IS IN PROGRESS. THE INVESTIGATION INTO THIS EVENT IS STILL BEING CARRIED OUT. A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS WITH THE INVESTIGATION CONCLUSIONS.
COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(6)(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). PMA/510(K) # K051124 / K163169. PROBLEM STATEMENT: "A ZILVER BILIARY STENT WHICH WAS IMPLANTED HAS CRACKED AND BROKEN. THE STENT IS STILL IN SITU AND WILL NOT BE REMOVED. THE INSERTION NOTES WERE NORMAL AND APPEARED THE STENT FUNCTIONED WELL. THEY ARE UNCERTAIN OF THE DATE THE FRACTURE OCCURRED AS IT ONLY CAME TO KNOWLEDGE WHEN THE PATIENT ON 31/1/18. THE PATIENT IS IN THE HOSPITAL NOW WITH SEPSIS, BUT DOCTOR IS NOT CERTAIN THE CAUSE OF SEPSIS IS DUE TO THE FRACTURED STENT.¿ "AS PER COMPLAINT FORM: UNAWARE OF WHEN OR HOW FRACTURE OCCURRED. IT WAS A NORMAL NO PROBLEM INSERTION. STENT EXPANDED AS NORMAL WHEN IMPLANTED. DATE OF STENT INSERTION WAS (B)(6) 2017 AND PATIENT ADMITTED INTO HOSPITAL AND SCANS TAKEN ON (B)(6) 2018 SHOWED FRACTURED STENT." DEVICE EVALUATION: THE ZIB6-40-10-8.0 DEVICE 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: IS THE COMPLAINT CONFIRMED? YES. STENT FRACTURE IS CONFIRMED. THE STENT LIKELY FRACTURED AT THE AMPULLARY DUODENAL JUNCTION. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE PATIENT'S ANATOMY: NONE. OBSERVATION OF DEVICE EFFECTS, RELATIVE TO THE DISEASE STATE: THE LARGE PORTAL HEPATIS MASS ENCASING THE PORTAL VEIN AND HEPATIC ARTERY HAD SIGNIFICANT POTENTIAL TO CAUSE SEPSIS THROUGH HEPATIC DUCT CONFLUENCE OBSTRUCTION OR STENT INGROWTH. OBSERVATION OF SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE: NONE. OBSERVATION OF ADDITIONAL DEVICE FINDINGS RELATIVE TO THE CLINICAL PERSPECTIVE: THE REPORTED SEPSIS COULD BE RELATED IF THE FRACTURE ALLOWED THE MAIN STENT SEGMENT TO STRAIGHTEN INTO THE AMPULLARY WALL RATHER THAN MAINTAIN ITS CURVATURE INTO THE DUODENUM. THE RESULTING OBSTRUCTION COULD HAVE CAUSED SEPSIS. ALTHOUGH A FRACTURE COULD CAUSE SEPSIS FROM PERFORATION, THE IMAGE PROVIDED NO EVIDENCE OF PERFORATION. FINDINGS: 1. A SINGLE, OBLIQUE MULTI-PLANAR RECONSTRUCTION CTA IMAGE OR THIN SECTION MAXIMUM INTENSITY PROJECTION IMAGE IS PROVIDED ALONG WITH THE COMPLAINT REPORT. ALTHOUGH THE INFORMATION CONTAINED IN THE COMPLAINT REPORT SIGNIFICANTLY AIDS STRUCTURE IDENTIFICATION, THE IMAGE IS CROPPED SO CLOSELY THAT IT IS IMPOSSIBLE TO DEFINITELY ASCERTAIN THE IDENTITY OF ALL THE STRUCTURES. 2. THE IMAGE DEMONSTRATES THE INFERIOR HALF OF THE ZIB6-40-10-8.0. AN 11MM LENGTH OF THE INFERIOR END WAS FRACTURED BUT STILL TOUCHING THE MAIN PORTION OF THE STENT. THE FRAGMENT PROJECTED INTO THE FLUID DENSITY CENTER OF AN ENHANCING TUBULAR STRUCTURE. LIKELY REPRESENTING THE DUODENAL LUMEN AT THE AMPULLA. 3. BECAUSE THE MAIN STENT SEGMENT WAS BENT TOWARDS THE FRAGMENT WHERE THE TWO PIECES TOUCH, THE FRAGMENT WAS STILL LIKELY ATTACHED BY AT LEAST A STENT STRUT. 4. SOFT TISSUE DENSITY PARTIALLY FILLING THE LUMEN OF THE MAIN STENT SEGMENT WAS MORE LIKELY ARTIFACT THAN TISSUE INGROWTH. ITS FRACTURED END PROJECTED INTO SOFT TISSUE, POSSIBLY THE WALL OF THE AMPULLA. THIS APPEARED TO OBSTRUCT STENT OUTFLOW. 5. THE PORTAL VEIN AND HEPATIC VEINS ARE ENCASED IN EXTRA PORTAL HEPATIS TISSUE LIKELY REPRESENTING THE MENTIONED MALIGNANCY. IMPRESSION: 1. STENT FRACTURE IS CONFIRMED. THE STENT LIKELY FRACTURED AT THE AMPULLARY DUODENAL JUNCTION. 2. THE REPORTED SEPSIS COULD BE RELATED IF THE FRACTURE ALLOWED THE MAIN STENT SEGMENT TO STRAIGHTEN INTO THE AMPULLARY WALL RATHER THAN MAINTAIN ITS CURVATURE INTO THE DUODENUM. THE RESULTING OBSTRUCTION COULD HAVE CAUSED SEPSIS. 3. ALTHOUGH A FRACTURE COULD CAUSE SEPSIS FROM PERFORATION, THE IMAGE PROVIDED NO EVIDENCE OF PERFORATION. 4. THE LARGE PORTAL HEPATIS MASS ENCASING THE PORTAL VEIN AND HEPATIC ARTERY HAD SIGNIFICANT POTENTIAL TO CAUSE SEPSIS THROUGH HEPATIC DUCT CONFLUENCE OBSTRUCTION OR STENT INGROWTH. ADDITIONAL COMMENTS WERE PROVIDED BY THE MEDICAL ADVISOR (REF ATT. 'RE 216601 - CLINICAL INPUT.'): "SEPSIS OR SUPERINFECTION IN BILIARY STENT IS NORMALLY RELATED TO THE DISLODGED OR MIGRATED BILIARY STENT (INDIAN J RADIO IMAGING. 2010 NOV; 20(4): 304¿306). THE OBSTRUCTION OF BILIARY DUCT COULD LEAD TO CHOLANGITIS OR SEPSIS. FRACTURE STENT IS IN GENERAL RELATED TO PERFORATION DUE TO THE STENT MIGRATION. IN THE CURRENT COMPLAINT, THE STENT IS STILL IN SITU AND WILL NOT BE REMOVED WHICH MEANS THERE WAS NO STENT MIGRATION OR DISLODGEMENT; FURTHERMORE, THE STENT APPEARED FUNCTION WELL, WHICH INDICATED THERE WAS NO OBSTRUCTION. THEREFORE, I WOULDN¿T THINK THE SEPSIS WAS CAUSED BY THE STENT FRACTURE ITSELF BUT MIGHT BE STENT-RELATED OR PROCEDURE-RELATED." COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE(S). THE IMAGE REVIEW FOUND THAT THE STENT WAS LIKELY FRACTURED AT THE AMPULLARY DUODENAL JUNCTION. POSSIBLE CAUSES FOR THIS OCCURRENCE COULD INCLUDE THE INGROWTH OF THE LARGE PORTAL HEPATIC MASS. THE INGROWTH COULD HAVE APPLIED FORCES TO THE STENT, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE STENT FRACTURING. THE PATIENT WAS TREATED FOR SEPSIS. THE IMAGE REVIEW SUGGESTED THAT THE SEPSIS COULD HAVE BEEN CAUSED BY THE STENT FRACTURE ALLOWING THE MAIN STENT SEGMENT TO STRAIGHTEN INTO THE AMPULLARY WALL OR THE HEPATIC PORTAL MASS BLOCKING THE STENT TO BECOME OBSTRUCTED. IN ADDITION, THE IMAGE REVIEW STATED THAT PERFORATION FROM THE FRACTURED STENT STRUTS COULD HAVE CAUSED SEPSIS, BUT THAT THERE WAS NO EVIDENCE OF PERFORATION IN THE IMAGES. HOWEVER, AS THE DEVICE WAS NOT AVAILABLE AND THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL ZILVER 635 BILIARY DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY AS PER FQC. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS 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. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE(S). THE IMAGE REVIEW FOUND THAT THE STENT WAS LIKELY FRACTURED AT THE AMPULLARY DUODENAL JUNCTION. THE RISK WAS DETERMINED TO BE MODERATE (CATEGORY IIB). ACCORDING TO THE INITIAL REPORTER, THE PATIENT WAS TREATED FOR SEPSIS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS INITIAL MDR IS BEING SUBMITTED DUE TO SERIOUS INJURY. THE PATIENT CONTRACTED SEPSIS AFTER THE STENT FRACTURED. A ZILVER BILIARY STENT WHICH WAS IMPLANTED HAS CRACKED AND BROKEN. THE STENT IS STILL IN SITU AND WILL NOT BE REMOVED. THE INSERTION NOTES WERE NORMAL AND APPEARED THE STENT FUNCTIONED WELL. THEY ARE UNCERTAIN OF THE DATE THE FRACTURE OCCURRED AS IT ONLY CAME TO KNOWLEDGE WHEN THE PATIENT ON (B)(6) 2018. THE PATIENT IS IN THE HOSPITAL NOW WITH SEPSIS, BUT DOCTOR IS NOT CERTAIN THE CAUSE OF SEPSIS IS DUE TO THE FRACTURED STENT. "AS PER COMPLAINT FORM": UNAWARE OF WHEN OR HOW FRACTURE OCCURRED. IT WAS A NORMAL NO PROBLEM INSERTION. STENT EXPANDED AS NORMAL WHEN IMPLANTED. DATE OF STENT INSERTION WAS (B)(6) 2017 AND PATIENT ADMITTED INTO HOSPITAL AND SCANS TAKEN ON (B)(6) 2018 SHOWED FRACTURED STENT.
THIS FOLLOW UP MDR IS BEING SUBMITTED AS THE INVESTIGATION IS IN PROGRESS, A FOLLOW UP REPORT WILL BE SENT WITHIN 30 DAYS. INITIAL MDR SUBMITTED DUE TO SERIOUS INJURY. THE PATIENT CONTRACTED SEPSIS AFTER THE STENT FRACTURED. A ZILVER BILIARY STENT WHICH WAS IMPLANTED HAS CRACKED AND BROKEN. THE STENT IS STILL IN SITU AND WILL NOT BE REMOVED. THE INSERTION NOTES WERE NORMAL AND APPEARED THE STENT FUNCTIONED WELL. THEY ARE UNCERTAIN OF THE DATE THE FRACTURE OCCURRED AS IT ONLY CAME TO KNOWLEDGE WHEN THE PATIENT ON (B)(6) 2018. THE PATIENT IS IN THE HOSPITAL NOW WITH SEPSIS, BUT DOCTOR IS NOT CERTAIN THE CAUSE OF SEPSIS IS DUE TO THE FRACTURED STENT. "AS PER COMPLAINT FORM": UNAWARE OF WHEN OR HOW FRACTURE OCCURRED. IT WAS A NORMAL NO PROBLEM INSERTION. STENT EXPANDED AS NORMAL WHEN IMPLANTED. DATE OF STENT INSERTION WAS (B)(6) 2017 AND PATIENT ADMITTED INTO HOSPITAL AND SCANS TAKEN ON (B)(6) 2018 SHOWED FRACTURED STENT.
THIS FOLLOW UP MDR IS BEING SUBMITTED TO UPDATE THE INVESTIGATION RESULTS. INITIAL MDR SUBMITTED DUE TO SERIOUS INJURY. THE PATIENT CONTRACTED SEPSIS AFTER THE STENT FRACTURED. A ZILVER BILIARY STENT WHICH WAS IMPLANTED HAS CRACKED AND BROKEN. THE STENT IS STILL IN SITU AND WILL NOT BE REMOVED. THE INSERTION NOTES WERE NORMAL AND APPEARED THE STENT FUNCTIONED WELL. THEY ARE UNCERTAIN OF THE DATE THE FRACTURE OCCURRED AS IT ONLY CAME TO KNOWLEDGE WITH THE PATIENT ON (B)(6) 2018. THE PATIENT IS IN THE HOSPITAL NOW WITH SEPSIS, BUT DOCTOR IS NOT CERTAIN THE CAUSE OF SEPSIS IS DUE TO THE FRACTURED STENT. "AS PER COMPLAINT FORM": UNAWARE OF WHEN OR HOW FRACTURE OCCURRED. IT WAS A NORMAL NO PROBLEM INSERTION. STENT EXPANDED AS NORMAL WHEN IMPLANTED. DATE OF STENT INSERTION WAS (B)(6) 2017 AND PATIENT ADMITTED INTO HOSPITAL AND SCANS TAKEN ON (B)(6) 2018 SHOWED FRACTURED STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145606 | ZILVER 635 SELF-EXPANDING BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | 10827002372778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |