COTTON-LEUNG BILIARY STENT
Report
- Report Number
- 3001845648-2018-00053
- Event Type
- Death
- Date Received
- February 14, 2018
- Report Date
- February 14, 2018
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Report Source
- Manufacturer report
- Reporter Location
- ZA
- 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.
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. AS 6 SEPARATE PATIENTS WERE INVOLVED IN THESE COMPLAINTS, 6 COMPLAINT FILES HAVE BEEN OPENED TO ADDRESS EACH OF THESE. (B)(4) WILL ADDRESS THE 2 PATIENT DEATHS. (B)(4) WILL ADDRESS THE ISSUES EXPERIENCED WITH THE REMAINING 4 PATIENTS. IT MAY BE NOTED THAT THERE IS NO EVIDENCE THAT IT WAS IN FACT A COOK MEDICAL STENT INVOLVED IN THESE COMPLAINTS. IT WAS MOST LIKELY THAT FROM ANOTHER MANUFACTURER AS THE CUSTOMER MENTIONED THAT THESE EVENTS OCCURRED IN DECEMBER 2017 AND THEY BELIEVE THAT THERE WERE NO COOK MANUFACTURED STENTS IN STOCK AT THIS TIME. HOWEVER A CONSERVATIVE APPROACH HAS BEEN TAKEN AND A RISK ASSESSMENT HAS BEEN COMPLETED. ADDITIONAL INFORMATION 29 JAN 2018; 1. DID THE PATIENTS HAVE ANY PRE-EXISTING CONDITIONS? ¿NO PATIENTS HAD ANY PRE-EXISTING CONDITIONS THAT WOULD HAVE CONTRIBUTED TO STENT BLOCKAGE.¿ 2. ANY CONTRAINDICATIONS? ¿NO PATIENTS HAD ANY CONTRAINDICATIONS TO AN ERCP OR PLASTIC STENT¿ 3. WHERE ANY OF THE STENTS REUSED? ¿AS YOU ARE AWARE WE PLACE PATIENT SAFETY FIRST AND NO CONSUMABLES ARE REUSED WITHIN OUR UNIT.¿ 4. DID ANY OF THE PATIENTS REQUIRE MULTIPLE STENTS? ¿ALL STENT BLOCKAGES HAVE BEEN WITH ONE SINGLE STENT.¿ 5. HOW DID THE CONDITION OF THE PATIENTS DETERIORATE IN EACH CASE?¿ PATIENTS DEVELOPED CHOLANGITIS AFTER EARLY BLOCKAGE, SOME WITH MULTI-ORGAN DYSFUNCTION AND SOME WITH DEATH¿ 6. WHAT TYPE OF INFECTION OCCURRED? ¿POLYMICROBIAL INFECTION MOST WITH GIT ORGANISMS WITH HIGH LEVELS OF RESISTANCE¿ 7. WHAT IS THE CAUSE OF DEATH OF THAT 2 PATIENTS? ¿SEPTIC SHOCK WITH MULTI-ORGAN FAILURE¿ 8. ARE ANY OF THE PRODUCTS BEING RETURNED? ¿THESE PRODUCTS HAVE ALREADY BEEN USED AND HENCE CANNOT BE RETURNED¿ 9. ARE THERE ANY IMAGES AVAILABLE? ¿WE HAVE CT SCANS OF THESE PATIENTS AND THEIR CHOLANGIOGRAMS¿ 10. WAS THERE WAS A BLACK MARKER BAND PRESENT ON THE STENTS THAT YOU HAVE REMOVED? ¿THE ENTIRE STENT WAS REMOVED SOMETIMES IT IS DIFFICULT TO SEE THE MARKERS AS THEY ARE COVERED IN BILE AND SLUDGE.¿ ADDITIONAL INFORMATION 31 JAN 2018; JUST TO CLARIFY ON THE BELOW; ¿THE ENTIRE STENT WAS REMOVED SOMETIMES IT IS DIFFICULT TO SEE THE MARKERS AS THEY ARE COVERED IN BILE AND SLUDGE.¿ REGARDLESS OF COLOUR, WERE THERE ANY MARKER BANDS PRESENT ON THESE STENTS? ¿I HEAR WHAT THEY ARE ASKING FOR AND I DO VERY WELL UNDERSTAND WHY THIS QUESTION HAS BEEN ASKED. WHAT I UNDERSTOOD FROM THE CUSTOMER WAS THAT THEY HAVE NOT TAKEN NOTICE OF THE MARKERS/ABSENT OF MARKERS ON THE STENT AT THE TIME THE STENTS WAS REMOVED. I UNDERSTOOD THAT THEIR CONCERN WAS WITH PATIENTS UNDER EMERGENCY CONDITIONS. AS THE STENTS WAS JUST GIVEN TO THE NURSING STAFF AND THROWN AWAY, THEY SIMPLY CANNOT RECALL AND GIVE YOU THE ANSWER YOU ARE LOOKING FOR. FOR THIS REASON, THE CUSTOMER HAVE CALLED IN BOTH THE COMPANIES WHO¿S PRODUCTS THEY NORMALLY USED AND HAVE ASKED BOTH OF US TO INVESTIGATE.¿ ADDITIONAL INFORMATION 28 FEB 2018; PRE-EXISTING CONDITIONS OF THE 6 PATIENTS INVOLVED WERE AS FOLLOW: ¿ 2 X PATIENTS HAD PANCREAS HEAD MALIGNANCIES THAT WAS RESECTABLE BUT ENDED UP IN ICU BEFORE THEY COULD BE OPERATED ON - ¿ ONE OF THESE PATIENTS DIED DUE TO COMPLICATIONS AND INFECTION AFTER THE STENT BLOCKED ¿ A 3RD PATIENT ALSO HAD PANCREAS HEAD MALIGNANCY ¿ 1 X PATIENT HAD COMMON BILE DUCT MALIGNANCY ¿ 2 X PATIENTS HAD CBD OBSTRUCTION DUE TO GALL STONES ¿ ONE OF THESE PATIENTS DIED DUE TO COMPLICATIONS AND INFECTION AFTER THE STENT BLOCKED BASED ON THE LIMITED INFORMATION PROVIDED, THE USER BELIEVES THAT IF IT WERE COOK STENTS INVOLVED IN THIS CASE THEN THEY WOULD LIKELY BE CLSO-10 DEVICES. THEREFORE, THIS INVESTIGATION WILL FOCUS ON CLSO STENTS. MULTIPLE REQUESTS HAVE BEEN MADE FOR FURTHER INFORMATION AS WELL AS PATIENT CT SCANS AND CHOLANGIOGRAMS. THIS COMPLAINT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED. CLINICAL INPUT: STENTS ARE INTENDED TO PROVIDE DRAINAGE AND CAN BECOME INHIBITED BY THE ¿SLUDGE¿ THAT RUNS THROUGH/AROUND THEM PATIENTS PRE-EXISTING CONDITIONS THAT I¿VE LISTED (FACTORS) COULD CONTRIBUTE TO STENT BLOCKAGE. THE INTENDED USE FOR STENTS TO ¿DRAIN OBSTRUCTED BILIARY/PANCREATIC DUCTS. PATIENTS DEVELOPED CHOLANGITIS AFTER EARLY BLOCKAGE, SOME WITH MULTI-ORGAN DYSFUNCTION AND SOME WITH DEATH. ACUTE CHOLANGITIS IS A BACTERIAL INFECTION SUPERIMPOSED ON AN OBSTRUCTION OF THE BILIARY TREE MOST COMMONLY FROM A GALLSTONE, BUT IT MAY BE ASSOCIATED WITH NEOPLASM OR STRICTURE. THE CLASSIC TRIAD OF FINDINGS IS RIGHT UPPER QUADRANT (RUQ) PAIN, FEVER, AND JAUNDICE. A PENTAD MAY ALSO BE SEEN, IN WHICH MENTAL STATUS CHANGES AND SEPSIS ARE ADDED TO THE TRIAD. A SPECTRUM OF CHOLANGITIS EXISTS, RANGING FROM MILD SYMPTOMS TO FULMINANT OVERWHELMING SEPSIS. THUS, THERAPEUTIC OPTIONS FOR PATIENT MANAGEMENT INCLUDE BROAD-SPECTRUM ANTIBIOTICS AND, POTENTIALLY, EMERGENCY DECOMPRESSION OF THE BILIARY TREE.¿ COMPLICATIONS OF PANCREATITIS, CHOLANGITIS, INFECTION, SEPSIS AND SO ON HAVE BEEN COVERED IN THE IFU, INFECTION OCCURRED IN THESE CASES IS NOT AN UNKNOWN POTENTIAL RISK. A FEW OF FACTORS WOULD CONTRIBUTE TO THE BLOCKAGE OF PLASTIC STENT SUCH AS MICROBIAL COLONIZATION, DUODENAL REFLUX OF FOOD CONSTITUENTS, PHYSICOCHEMICAL PROPERTIES OF THE CONSTITUTIVE MATERIALS, SURFACE IRREGULARITIES OF THE DEVICES PROMOTING MICROBIAL BIOFILM FORMATION, AND BILIARY SLUDGE ACCUMULATION. ALSO, POLYMICROBIAL INFECTION WITH GIT ORGANISMS WITH HIGH LEVELS OF RESISTANCE COULD BE RESPONSIBLE FOR HASTENING THE ONSET OF STENT OCCLUSION. THERE ARE STILL QUESTIONS THAT WE COULD ASK, SUCH AS HOW MANY STENTS HAD BEEN USED IN THAT HOSPITAL? HOW MANY COMPLAINTS THAT WE HAVE RECEIVED? WAS THE SAME PHYSICIAN OR TEAM THAT PERFORMED THESE PROCEDURES? HAD THE PHYSICIAN MADE THE APPROPRIATE DECISION PLACING THE STENT AT RIGHT TIME INTO RIGHT PATIENTS? (I.E. WERE THOSE PATIENTS TOO SICK TO BE INSERT A STENT AT THE FIRST PLACE?) ETC. EVEN THOSE QUESTIONS WOULD BE ANSWERED, WE PROBABLY STILL COULDN¿T FIGURE THE ACTUAL REASON THAT THE STENTS GOT BLOCKED. LAB EVALUATION: THIS DEVICE WAS NOT RETURNED TO CIRL FOR A LAB EVALUATION. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING. A FEW OF FACTORS WOULD CONTRIBUTE TO THE BLOCKAGE OF PLASTIC STENT SUCH AS MICROBIAL COLONIZATION, DUODENAL REFLUX OF FOOD CONSTITUENTS, PHYSICOCHEMICAL PROPERTIES OF THE CONSTITUTIVE MATERIALS, SURFACE IRREGULARITIES OF THE DEVICES PROMOTING MICROBIAL BIOFILM FORMATION, AND BILIARY SLUDGE ACCUMULATION. AS WELL AS THIS, POLYMICROBIAL INFECTION WITH GIT ORGANISMS WITH HIGH LEVELS OF RESISTANCE COULD BE RESPONSIBLE FOR HASTENING THE ONSET OF STENT OCCLUSION. IFU REVIEW: IT MAY BE NOTED THAT ACCORDING TO THE INSTRUCTIONS FOR USE, IFU0045-6, THE USER IS INSTRUCTED TO: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. CHOLANGITIS, INFECTION AND SEPSIS ARE LISTED UNDER THE POTENTIAL COMPLICATIONS SECTION OF THE IFU. FQC/ PRD REVIEW: PRIOR TO DISTRIBUTION, ALL BILIARY DEVICES ARE SUBJECTED TO 100% INSPECTION TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. IT MAY BE NOTED THAT DUE TO THE FACT ALL CLSO-10 DEVICES ARE INSPECTED IN- HOUSE AND ALSO THAT THE USER WAS IN FACT ABLE TO PLACE THE STENTS SUCCESSFULLY, IT IS UNLIKELY THAT THE STENT DESIGN ATTRIBUTED TO THE STENT BLOCKAGE. THERE IS ALSO A VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. DOCUMENT REVIEW: AS THE LOT NUMBER IS UNKNOWN, IT IS NOT POSSIBLE TO PERFORM A DOCUMENT REVIEW. SUMMARY: THIS COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THIS IS A CONSERVATIVE ASSESSMENT BASED ON THE USER FACILITY REPORTING THEY COULD NOT CONFIRM IF THESE PATIENTS HAD A COOK MANUFACTURED STENT. SIX X INCIDENTS WHERE BILIARY PLASTIC STENTS HAVE BEEN PLACED IN PATIENTS DURING ERCP PROCEDURES. THE STENTS WAS PLACED TO PROVIDE DRAINAGE TO IMPROVE THE "PATIENT'S" CONDITIONS FOR SURGERY. IN 2 WEEKS TIME THE "PATIENT'S" CONDITIONS DETERIORATED DUE TO ALLEGED BLOCKAGE OF STENTS. THE HOSPITAL HAD NO PREVIOUS TRACKING SYSTEM IN PLACE, THEREFORE THERE IS NO PROOF OF THE PRODUCTS USED LOT NUMBERS OR CODES.
THIS IS A CONSERVATIVE ASSESSMENT BASED ON THE USER FACILITY REPORTING THEY COULD NOT CONFIRM IF THESE PATIENTS HAD A COOK MANUFACTURED STENT. SIX X INCIDENTS WHERE BILIARY PLASTIC STENTS HAVE BEEN PLACED IN PATIENTS DURING ERCP PROCEDURES. THE STENTS WAS PLACED TO PROVIDE DRAINAGE TO IMPROVE THE "PATIENT'S" CONDITIONS FOR SURGERY. IN 2 WEEKS TIME THE "PATIENT'S" CONDITIONS DETERIORATED DUE TO ALLEGED BLOCKAGE OF STENTS. THE HOSPITAL HAD NO PREVIOUS TRACKING SYSTEM IN PLACE, THEREFORE THERE IS NO PROOF OF THE PRODUCTS USED LOT NUMBERS OR CODES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114166 | COTTON-LEUNG BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |