EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - PARTIALLY COVERED
Report
- Report Number
- 3001845648-2017-00572
- Event Type
- Death
- Date Received
- November 30, 2017
- Report Date
- November 2, 2017
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002231396
- PMA / PMN Number
- K121430
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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. INFORMATION WAS PROVIDED ON THIS COMPLAINT 02 NOV 2017: ¿THE DISTAL END OF STENT DID NOT OPEN & THE PATIENT DIED 5 DAYS LATER. THE PHYSICIAN REMOVED THE SCOPE BEFORE HE CONFIRMED OR NOTICED AND LIQUID OR BILE FLOWING FROM THE DEPLOYED STENT. THE REP WAS NOT IN ATTENDANCE FOR THE CASE BUT WAS IN THE GROUP WHILE I WAS HAVING THE CONVERSATION WITH THE PHYSICIAN AND THE REP WONDERED IF THERE WAS CONGEALED BLOOD AT THE DISTAL END OF THE STENT WHICH WAS IMPEDING THE FLOW. THE PATIENT RETURNED TO HOSPITAL FIVE DAYS AFTER THE STENT WAS PLACED WITH COMPLICATIONS AND DIED IN HOSPITAL.¿ FULL COMPLAINT INFORMATION WAS REPORTED AS FOLLOWS ON 07 NOV 2017: ¿THE PATIENT INVOLVED WITH THIS COMPLAINT HAD AN ADVANCED PANCREATIC CANCER (ADENOCARCINOMA) AND HAD INDICATION OF PALLIATION. SO, THE PHYSICIAN DECIDED TO USE AN EVOLUTION BILIARY PC FOR THIS PATIENT. THE PHYSICIAN REPORTED TO ME THAT EVERYTHING OCCURRED FINE ON THE DEPLOYMENT OF THE STENT AND AFTER HE FINISHED THE PROCEDURE, HE COULD NOT SEE THE DRAINAGE OF THE BILE. SO, HE THOUGHT THAT HE HAD DEPLOYED THE STENT ON THE CYST DUCT (FYI - THIS PATIENT DID NOT HAVE GALLBLADDER) BUT HE CHECKED THE RATIO X AND THE POSITION WAS GREAT BUT THE DISTAL AND OF THE STENT DID NOT OPEN (THIS WAS IN THE END OF THE PROCEDURE). SO THE PATIENT BACK TO HIS HOME. AFTER ONE WEEK THIS PATIENT WAS ADMITTED ON UTI WITH SEPSIS AND DIED AFTER 2 DAYS. THE OPINION OF THE PHYSICIAN IS THAT THE DISTAL END OF THE STENT DID NOT OPEN AFTER 48 HOURS AND DID NOT DRAIN THE BILIARY DUCT. SO, I DECIDED TO CALL TO THE REP FROM THE DISTRIBUTOR. SHE WAS WITH THE PHYSICIAN AT THIS PROCEDURE. SHE REPORTED ME THAT THE PROCEDURE FINISH WITH NO ISSUE AND BOTH DISTAL AND PROXIMAL END OF THE STENT OPENED AFTER HE DEPLOYED. SHE TOLD ME THAT AFTER PROCEDURE HE WAS WITH A BIG DOUBT IF HE HAD DEPLOYED THE STENT ON THE CORRECT POSITION AND TALKED TO HER A LOT ABOUT IT MINUTES AFTER THE PROCEDURE. SHE HAS CERTAIN THAT THE ISSUE IS NOT WITH OUR STENT BECAUSE SHE WAS THERE AND THE STENT DEPLOYED AND OPEN WITH NO ISSUES.¿ AS PER COMPLAINT FORM: "THE CUSTOMER REPORTED DIRECTLY TO COOK A PROBLEM WITH THE PRODUCT G23139- EVO-PC-10-11-6-B LOT: CF1351527. ACCORDING TO REPORT, THE PHYSICIAN DECIDED TO USE THE PRODUCT IN PATIENT WITH ADENOCARCINOMA. OCCURRED EVERYTHING DURING THE PROCEDURE AND THAT IN THE FINAL, THE DOCTOR CHECKED THROUGH X-RAY THAT THE DISTAL PART OF THE STENT WAS NOT OPENED. PATIENT WENT HOME AND RETURNED TO THE HOSPITAL AFTER 1 WEEK WITH SEPSIS AND WENT TO DEATH AFTER 2 DAYS. THE CONSULTANT WAS PRESENT IN THE PROCEDURE AND REPORTED THAT THE SAME HAD OCCURRED NORMALLY. AFTER THE PROCEDURE THE PHYSICIAN TALKED WITH THE CONSULTANT THAT REPORTED THAT THE DISTAL AND PROXIMAL PART OF THE STENT OPENS NORMALLY AFTER 48H OF THE IMPLANT. AFTER THE RETURN OF THE PATIENT TO THE ICU, AN IMAGE WAS NOT PERFORMED TO VERIFY THE PROBLEM. SO, I DECIDED TO CALL TO THE REP FROM THE DISTRIBUTOR . SHE WAS WITH THE PHYSICIAN AT THIS PROCEDURE. SHE REPORTED ME THAT THE PROCEDURE FINISH WITH NO ISSUE AND BOTH DISTAL AND PROXIMAL END OF THE STENT OPENED AFTER HE DEPLOYED. SHE TOLD ME THAT AFTER PROCEDURE HE WAS WITH A BIG DOUBT IF HE HAD DEPLOYED THE STENT ON THE CORRECT POSITION AND TALKED TO HER A LOT ABOUT IT MINUTES AFTER THE PROCEDURE. SHE HAS CERTAIN THAT THE ISSUE IS NOT WITH OUR STENT BECAUSE SHE WAS THERE AND THE STENT DEPLOYED AND OPEN WITH NO ISSUES." THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR RETURN TO COOK IRELAND FOR EVALUATION. FLUOROSCOPIC IMAGING WAS PROVIDED FOR REVIEW, CIRL ENGINEERS HAD THE FOLLOWING COMMENTS: ¿STENT OPENED AT EITHER END WITH SOME FLOW VISIBLE (WHITE IN IMAGES) STRICTURE TIGHT¿ GLOBAL PROJECT MANAGER FOR ENDOSCOPY HAD THE FOLLOWING COMMENTS: ¿PICTURE 1 YOU CAN SEE THAT THE TUMOR IS COMING FROM LEFT AND RIGHT, WONDER IF IT IS IMPRESSION FROM OUTSIDE OR REAL TUMOR ON INSIDE OF THE CBD, AT THE END IT DOES NOT MATTER AS FOR SURE IT IS HIGHLY IRREGULAR. ON IMAGE TWO YOU SEE THAT THE DISTAL PART OF THE STENT BENDS TO THE LEFT SIDE OF THE PATIENT JUST ABOVE THE STRICTURE, THE THIRD IMAGE YOU SEE THAT THERE IS ALREADY A LITTLE OPENING OF THE STENT IN THE MIDDLE AND THAT IT PUSHED ITSELF TO THE LEFT WALL MORE THEN ON THE SECOND. WHAT COULD HAVE HAPPENED HERE IS THAT STENT DEPLOYED OVER TIME AND THAT IT WENT INTO THE WALL AND NOT OPENING FROM TOP OF THE LIVER. THE STENT OPENED NO DOUBT, I THINK THIS SHOW WRONG CHOSEN LENGTH IN MY OPINION WITH CONSEQUENCE OF STENT TOP FACING THE WALL INSTEAD OF THE LUMEN.¿ CLINICAL HAD THE FOLLOWING FEEDBACK: 1. ¿IF THE STENT WAS NOT OPENED POST PROCEDURE, THE BLOCKAGE WOULDN¿T BE RELIEVED WHICH WOULD CAUSE INFECTION SUCH AS CHOLANGITIS OR PANCREATITIS. 2. EVEN THE PROXIMAL END OF STENT DIDN¿T OPEN AFTER PROCEDURE PER PHYSICIAN¿S DESCRIPTION, THE DRAINAGE OF THE BILE CANNOT ALWAYS BE OBSERVED IMMEDIATELY AFTER THE STENT DEPLOYMENT, AND IT ALSO TAKES TIME FOR THE STENT TO BE FULLY OPENED. 3. OUR REP REPORTED THAT THE PROCEDURE FINISH WITH NO ISSUE AND BOTH DISTAL AND PROXIMAL END OF THE STENT OPENED AFTER HE DEPLOYED. 4. UTI IS QUIET COMMON IN TERMINAL CANCER PATIENTS, URINARY AND RESPIRATORY TRACTS ARE THE MOST FREQUENTLY INVOLVED SITES OF INFECTION. THE UTI IN THIS PATIENT WAS UNLIKELY RELATED TO THE STENT DEPLOYMENT. 5. IF THE UNOPENED STENT HAD CAUSED INFECTION SUCH AS CHOLANGITIS OR PANCREATITIS, THE PATIENT WOULD HAVE HAD THE SYMPTOMS SUCH AS ABDOMINAL PAIN ON THE UPPER RIGHT OR MIDDLE, FEVER AND CHILLS, NAUSEA AND VOMITING ETC.. HOWEVER, NONE OF WHICH HAD BEEN REPORTED. 6. FOR THE WORSE SCENARIO THAT UTI WAS SECONDARY TO ACUTE PANCREATITIS DUE TO UNOPENED STENT, THE PROBABILITY IS LOW (6.1%) WITH LATE ONSET (~20.5 DAYS LATER) AFTER PNEUMONIA (~11 DAYS), BACTEREMIA (~14 DAYS), GI INFECTION (~17 DAYS) ACCORDING TO A STUDY1. THIS PATIENT PASSED AWAY ~9 DAYS (ONE WEEK + 2 DAYS) AFTER THE PROCEDURE WHICH WAS NOT LIKELY LINK TO PANCREATITIS-CAUSED UTI. IN SUMMARY, COMPLICATIONS COULD OCCUR IF THE STENT NOT OPENING POST PROCEDURE, HOWEVER THIS OCCURRENCE WAS UNLIKELY ASSOCIATE WITH PATIENT DEATH.¿ AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, FROM THE INFORMATION PROVIDED FROM ENDOSCOPY ¿THE STENT OPENED NO DOUBT¿. ALSO, ACCORDING TO INFORMATION SUPPLIED BY THE REP FROM THE DISTRIBUTOR WHO WAS WITH THE PHYSICIAN AT THE PROCEDURE: ¿THE PROCEDURE FINISH WITH NO ISSUE AND BOTH DISTAL AND PROXIMAL END OF THE STENT OPENED AFTER HE DEPLOYED.¿ ¿AFTER PROCEDURE HE WAS WITH A BIG DOUBT IF HE HAD DEPLOYED THE STENT ON THE CORRECT POSITION AND TALKED TO HER A LOT ABOUT IT MINUTES AFTER THE PROCEDURE. SHE HAS CERTAIN THAT THE ISSUE IS NOT WITH OUR STENT BECAUSE SHE WAS THERE AND THE STENT DEPLOYED AND OPEN WITH NO ISSUES.¿ AS PER CLINICAL FEEDBACK FROM WEI: ¿COMPLICATIONS COULD OCCUR IF THE STENT NOT OPENING POST PROCEDURE, HOWEVER THIS OCCURRENCE WAS UNLIKELY ASSOCIATE WITH PATIENT DEATH.¿ AS PER FEEDBACK FROM CIRL ENGINEERS & PRODUCT MANAGER: ¿STENT OPENED AT EITHER END WITH SOME FLOW VISIBLE (WHITE IN IMAGES). STRICTURE WAS TIGHT. SEPSIS CAN BE CAUSED BY SEVERAL DIFFERENT THINGS.¿ AS PER IFU: ¿AFTER DEPLOYMENT, FLUOROSCOPICALLY CONFIRM FULL STENT EXPANSION.¿ THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION, ALL EVO-PC-10-11-6-BDEVICES 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 THIS EVOLUTION DEVICE OF LOT REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT #; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #. AS PER INSTRUCTIONS FOR USE: ¿AFTER DEPLOYMENT, FLUOROSCOPICALLY CONFIRM FULL STENT EXPANSION.¿ ON REVIEW OF THE INFORMATION PROVIDED, THERE IS EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM CLINICAL, ENGINEERING AND SPECIALIST FEEDBACK RECEIVED, IT IS DETERMINED THAT THE PATIENT¿S DEATH IS NOT DUE TO DEVICE MALFUNCTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS REPORT IS BASED ON A REPORT OF A PATIENT DEATH 5 DAYS AFTER A PROCEDURE USING A COOK IRELAND MANUFACTURED EVOLUTION DEVICE. INVESTIGATION CONCLUSIONS DETERMINE THE PATIENT'S DEATH WAS NOT DUE TO A DEVICE MALFUNCTION. A POSSIBILITY EXISTS THE INCORRECT SIZE WAS SELECTED BY THE USER BUT THIS HAS NOT BEEN CONFIRMED. ERRING ON THE SIDE OF CAUTION A REPORT IS SUBMITTED BASED ON CONFLICTING INFORMATION FROM THE USER AND THE INVESTIGATION CONCLUSIONS AND IN CASES OF DOUBT A REPORT IS SUBMITTED. COMPLAINT DESCRIPTIONS RECEIVED: THE PATIENT "INVOLVED" WITH THIS COMPLAINT HAD AN ADVANCED PANCREATIC CANCER (ADENOCARCINOMA) AND HAD INDICATION OF "PALLIATION". SO, THE PHYSICIAN DECIDED TO USE AN EVOLUTION BILIARY PC FOR THIS PATIENT. THE PHYSICIAN REPORTED TO ME THAT EVERYTHING OCCURRED FINE ON THE DEPLOYMENT OF THE STENT AND AFTER HE FINISHED THE PROCEDURE, HE COULD NOT SEE THE DRAINAGE OF THE BILE. SO, HE THOUGHT THAT HE HAD DEPLOYED THE STENT ON THE CYST DUCT (FYI - THIS PATIENT DID NOT HAVE GALLBLADDER) BUT HE CHECKED THE RAIO X AND THE POSITION WAS GREAT BUT THE DISTAL AND OF THE STENT DID NOT OPEN (THIS WAS IN THE END OF THE PROCEDURE). SO THE PATIENT BACK TO HIS HOME. AFTER ONE WEEK THIS PATIENT WAS ADMITTED ON UTI WITH SEPSIS AND DIED AFTER 2 DAYS. THE OPINION OF THE PHYSICIAN IS THAT THE DISTAL END OF THE STENT DID NOT OPEN AFTER 48 HOURS AND DID NOT DRAIN THE BILIARY DUCT. "AS PER COMPLAINT FORM": THE CUSTOMER REPORTED DIRECTLY TO COOK A PROBLEM WITH THE PRODUCT G23139- EVO-PC-10-11-6-B LOT: CF1351527. ACCORDING TO REPORT, THE PHYSICIAN DECIDED TO USE THE PRODUCT IN PATIENT WITH ADENOCARCINOMA. OCCURRED EVERYTHING DURING THE PROCEDURE AND THAT IN THE FINAL, THE DOCTOR CHECKED THROUGH X-RAY THAT THE DISTAL PART OF THE STENT WAS NOT OPENED. PATIENT WENT HOME AND RETURNED TO THE HOSPITAL AFTER 1 WEEK WITH SEPSIS AND WENT TO DEATH AFTER 2 DAYS. THE CONSULTANT WAS PRESENT IN THE PROCEDURE AND REPORTED THAT THE SAME HAD OCCURRED NORMALLY. AFTER THE PROCEDURE THE PHYSICIAN TALKED WITH THE CONSULTANT THAT REPORTED THAT THE DISTAL AND PROXIMAL PART OF THE STENT OPENS NORMALLY AFTER 48H OF THE IMPLANT. AFTER THE RETURN OF THE PATIENT TO THE ICU, AN IMAGE WAS NOT PERFORMED TO VERIFY THE PROBLEM. SO, I DECIDED TO CALL TO THE REP FROM THE DISTRIBUTOR. SHE WAS WITH THE PHYSICIAN AT THIS PROCEDURE. SHE REPORTED ME THAT THE PROCEDURE FINISH WITH NO ISSUE AND BOTH DISTAL AND PROXIMAL END OF THE STENT OPENED AFTER HE DEPLOYED. SHE TOLD ME THAT AFTER PROCEDURE HE WAS WITH A BIG DOUBT IF HE HAD DEPLOYED THE STENT ON THE CORRECT POSITION AND TALKED TO HER A LOT ABOUT IT MINUTES AFTER THE PROCEDURE. SHE HAS CERTAIN THAT THE ISSUE IS NOT WITH OUR STENT BECAUSE SHE WAS THERE AND THE STENT DEPLOYED AND OPEN WITH NO ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 849361 | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - PARTIALLY COVERED | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | 10827002231396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |