COTTON-LEUNG BILIARY STENT
Report
- Report Number
- 3001845648-2019-00063
- Event Type
- Death
- Date Received
- February 14, 2019
- Date of Event
- January 15, 2019
- Report Date
- April 22, 2019
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K851962
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
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. DEVICE & LAB EVALUATION: THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR A LAB EVALUATION. DOCUMENTS REVIEW INCLUDING IFU REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE CLSO-7-12 DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. PRIOR TO DISTRIBUTION ALL CLSO DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN CIRL PROCEDURES. THERE IS A 100% VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC AS PER QSI0975. IT MAY BE NOTED THAT ACCORDING TO INSTRUCTIONS FOR USE, IFU0045-6, "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION". THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE FOR THIS DEVICE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED DUE TO LIMITED INFORMATION AND AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING AS THE DEVICE WAS NOT RETURNED. IT MAY BE NOTED THAT BOTH MIGRATION AND PERFORATION ARE POTENTIAL COMPLICATIONS DOCUMENTED IN THE INSTRUCTIONS FOR USE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER INFORMATION PROVIDED, 3 DAYS AFTER STENT WAS PLACED SUCCESSFULLY, PATIENT PRESENTED TO A DIFFERENT FACILITY WITH A PERFORATED DUODENAL WALL, NO FURTHER INFORMATION WAS AVAILABLE. SEVERAL ATTEMPTS HAVE BEEN MADE TO GET FURTHER INFORMATION ON PATIENT OUTCOME, THERE HAS BEEN NO MORE INFORMATION PROVIDED AT THIS TIME, HOWEVER, IF FURTHER INFORMATION IS PROVIDED, INVESTIGATION AND RISK WILL BE UPDATED. CLINICAL PROVIDED THE FOLLOWING INPUT WITH RESPECT TO MANAGEMENT OF PERFORATION: ¿DUODENAL PERFORATION CAN BE MANAGED OR TREATED VIA SEVERAL METHODS. ¿ CONSERVATIVE MANAGEMENT OR NON-SURGICAL TREATMENT (ANTIBIOTICS AND OBSERVATION) DEPENDING ON THE STATUS OF THE PERFORATION SUCH AS SIZE, LEAKAGE AND PATIENT¿S CONDITION. ¿ MINIMAL INVASIVE MANAGEMENT SUCH AS COVER THE PERFORATED AREA WITH COVERED METAL STENTS OR ENDOCLIP TO CLOSE THE PERFORATION. ¿ SURGICAL PROCEDURE. MOST DUODENAL PERFORATION CAN BE TREATED WITH INTERVENTIONS ABOVE. IT COULD BE LIFE THREATENING OR CAUSE DEATH IF THE PERFORATION LEADS TO SEPSIS, BILIARY PERITONITIS OR EVEN PATIENT REFUSED SURGICAL INTERVENTION.¿ COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. INFORMATION UPDATE RECEIVED 30 APRIL 2019, POST FILE CLOSURE. SEE (B)(4) MEDWATCH REPORT (POSSIBLY RELATED)" IT IS ASSUMED THAT THIS INCIDENT IS RELATED TO THIS FILE. INFORMATION PROVIDED: "PT HAD A COOK STENT LACED DURING ERCP; 3 DAYS LATER, CT SHOWED MIGRATION WITH DUODENAL PERFORATION MD NEVER SEEN ANYTHING LIKE IT AND SUSPECTS DEVICE RELATED COMPLICATION." PATIENT OUTCOME REPORTED: "DEATH". NO FURTHER INFORMATION WAS AVAILABLE IN RELATION TO THIS CASE. CLINICAL HAVE PROVIDED THE FOLLOWING FEEDBACK: "FROM A CLINICAL PERSPECTIVE, I CANNOT CONCLUDE THE PATIENT¿S DEATH WAS RELATED TO THE STENT FOR SURE, BUT I CANNOT RULE OUT THE POSSIBILITY EITHER WITHOUT FURTHER INFORMATION."
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. DEVICE & LAB EVALUATION: THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR A LAB EVALUATION. DOCUMENTS REVIEW INCLUDING IFU REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE CLSO-7-12 DEVICE INVOLVED IN THIS COMPLAINT COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. PRIOR TO DISTRIBUTION ALL CLSO DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN CIRL PROCEDURES. THERE IS A 100% VISUAL INSPECTION OF THE PRODUCT AND PACKAGING AT PACKAGING, PACKAGING QC, AND POST STERILE QC. IT MAY BE NOTED THAT ACCORDING TO INSTRUCTIONS FOR USE, IFU0045-6, "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION". THERE IS NO EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE FOR THIS DEVICE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER COMPLAINT COULD NOT BE DETERMINED DUE TO LIMITED INFORMATION AND AS THE EXACT OPERATIONAL CONDITIONS OF USE COULD NOT BE REPLICATED IN THE LABORATORY SETTING AS THE DEVICE WAS NOT RETURNED. IT MAY BE NOTED THAT BOTH MIGRATION AND PERFORATION ARE POTENTIAL COMPLICATIONS DOCUMENTED IN THE INSTRUCTIONS FOR USE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER INFORMATION PROVIDED, 3 DAYS AFTER STENT WAS PLACED SUCCESSFULLY, PATIENT PRESENTED TO A DIFFERENT FACILITY WITH A PERFORATED DUODENAL WALL, NO FURTHER INFORMATION WAS AVAILABLE. SEVERAL ATTEMPTS HAVE BEEN MADE TO GET FURTHER INFORMATION ON PATIENT OUTCOME, THERE HAS BEEN NO MORE INFORMATION PROVIDED AT THIS TIME, HOWEVER, IF FURTHER INFORMATION IS PROVIDED, INVESTIGATION AND RISK WILL BE UPDATED. CLINICAL PROVIDED THE FOLLOWING INPUT WITH RESPECT TO MANAGEMENT OF PERFORATION: ¿DUODENAL PERFORATION CAN BE MANAGED OR TREATED VIA SEVERAL METHODS. CONSERVATIVE MANAGEMENT OR NON-SURGICAL TREATMENT (ANTIBIOTICS AND OBSERVATION) DEPENDING ON THE STATUS OF THE PERFORATION SUCH AS SIZE, LEAKAGE AND PATIENT¿S CONDITION. MINIMAL INVASIVE MANAGEMENT SUCH AS COVER THE PERFORATED AREA WITH COVERED METAL STENTS OR ENDOCLIP TO CLOSE THE PERFORATION. SURGICAL PROCEDURE. MOST DUODENAL PERFORATION CAN BE TREATED WITH INTERVENTIONS ABOVE. IT COULD BE LIFE THREATENING OR CAUSE DEATH IF THE PERFORATION LEADS TO SEPSIS, BILIARY PERITONITIS OR EVEN PATIENT REFUSED SURGICAL INTERVENTION.¿ COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
INFORMATION UPDATE RECEIVED 30 APRIL 2019, POST FILE CLOSURE. IT IS ASSUMED THAT THIS INCIDENT IS RELATED TO THIS FILE. INFORMATION PROVIDED: "PT HAD A COOK STENT LACED DURING ERCP; 3 DAYS LATER, CT SHOWED MIGRATION WITH DUODENAL PERFORATION MD NEVER SEEN ANYTHING LIKE IT AND SUSPECTS DEVICE RELATED COMPLICATION." PATIENT OUTCOME REPORTED: "DEATH".
AS REPORTED TO CUSTOMER RELATIONS: "CUSTOMER HAD STENT PLACED SUCCESSFULLY, WENT HOME, AND 3 DAYS LATER PRESENTED TO DIFFERENT FACILITY WITH A PERFORATED DUODENAL WALL." FDA MDR REPORTING REQUIRED - REPORTING REQUIRED BASED ON THE REQUIREMENT FOR A SURGICAL INTERVENTION AS THE "STENT PERFORATED THE PATIENT'S DUODENAL WALL."NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AS OCCURRING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133113 | COTTON-LEUNG BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |