UNKNOWN
Report
- Report Number
- 3001845648-2020-00062
- Event Type
- Injury
- Date Received
- January 29, 2020
- Date of Event
- April 26, 2019
- Report Date
- October 10, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K121430
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS IS A CORRECTION REPORT, SUBMITTED TO CORRECT SECTION D.3 MANUFACTURER'S ADDRESS AND SECTION F.14 MFG SITE FOR DEVICES TO COOK IRELAND LTD. IN THE LAST REPORT SUBMITTED THIS WAS SELECTED AS COOK INC IN ERROR. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THIS IS A CONSERVATIVE ASSESSMENT - WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, NATICK, MA, USA), NITI-S (TAEWOONG MEDICAL INC., SEOUL, SOUTH KOREA) AND EVOLUTION (COOK ENDOSCOPY, WINSTON-SALEM, NC, USA) SEMS WERE USED IN THIS STUDY. PLEASE NOTE, AS 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY, WE CANNOT CONFIRM THAT A COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT. THE EXACT RPN IS UNKNOWN THEREFORE THE MOST LIKELY COMMON NAME FOR THIS IS FGE - COOK EVOLUTION BILIARY STENT AND K121430 IS THE MOST LIKELY 510 K #.
DEVICE EVALUATION: THE EVO BILIARY STENT OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL '' A 17 YEARS RETROSPECTIVE STUDY ON MULTIPLE METAL STENTS FOR COMPLEX MALIGNANT HILAR BILIARY STRICTURES: SURVIVAL, STENTS PATENCY AND OUTCOMES OF RE-INTERVENTIONS FOR OCCLUDED METAL STENTS'' BOSKOSKI ET AL 2019. 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY; WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, NATICK, MA, USA), NITI-S (TAEWOONG MEDICAL INC., SEOUL, SOUTH KOREA) AND EVOLUTION (COOKENDOSCOPY, WINSTON-SALEM, NC, USA) SEMS WERE USED IN THIS STUDY. WE CANNOT CONFIRM THAT THE COOK STENT WAS RELATED TO THIS THIS SPECIFIC ADVERSE EVENT SO THIS IS A CONSERVATIVE ASSESSMENT. THIS FILE CAPTURES 79 CASES OF CHOLANGITIS. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO BILIARY STENT DEVICE IS FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED PRIOR TO DISTRIBUTION ALL EVO BILIARY STENT DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0062-5, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS STATES: POTENTIAL COMPLICATIONS ASSOCIATED WITH ECRP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, CHOLECYSTITIS, CHOLESTASIS, ASPIRATION, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. ADDITIONAL COMPLICATIONS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM; PERFORATION; OBSTRUCTION OF THE PANCREATIC DUCT; STENT MIGRATION; STENT OCCLUSION; INGROWTH DUE TO TUMOR OR EXCESSIVE HYPERPLASTIC TISSUE; TUMOR OVERGROWTH; STENT MISPLACEMENT, PAIN, FEVER, NAUSEA, VOMITING, INFLAMMATION, RECURRENT OBSTRUCTIVE JAUNDICE, BILE DUCT ULCERATION, DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION) ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, CHOLANGITIS IS LISTED AS A POTENTIAL COMPLICATION. INFORMATION RECEIVED IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT IT WAS THE COOK STENT THAT CONTRIBUTED TO THE EVENT. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT SUFFERED CHOLANGITIS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DEVICE EVALUATION: THE EVO BILIARY STENT OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL '' A 17 YEARS RETROSPECTIVE STUDY ON MULTIPLE METAL STENTS FOR COMPLEX MALIGNANT HILAR BILIARY STRICTURES: SURVIVAL, STENTS PATENCY AND OUTCOMES OF RE-INTERVENTIONS FOR OCCLUDED METAL STENTS'' BOSKOSKI ET AL 2019. 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY; WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, NATICK, MA, USA), NITI-S (TAEWOONG MEDICAL INC., SEOUL, SOUTH KOREA) AND EVOLUTION (COOKENDOSCOPY, WINSTON-SALEM, NC, USA) SEMS WERE USED IN THIS STUDY. WE CANNOT CONFIRM THAT THE COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT SO THIS IS A CONSERVATIVE ASSESSMENT. THIS FILE CAPTURES 79 CASES OF CHOLANGITIS. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO BILIARY STENT DEVICE IS FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED PRIOR TO DISTRIBUTION ALL EVO BILIARY STENT DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0062-5, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS STATES: POTENTIAL COMPLICATIONS ASSOCIATED WITH ECRP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, CHOLECYSTITIS, CHOLESTASIS, ASPIRATION, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. ADDITIONAL COMPLICATIONS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM; PERFORATION; OBSTRUCTION OF THE PANCREATIC DUCT; STENT MIGRATION; STENT OCCLUSION; INGROWTH DUE TO TUMOR OR EXCESSIVE HYPERPLASTIC TISSUE; TUMOR OVERGROWTH; STENT MISPLACEMENT, PAIN, FEVER, NAUSEA, VOMITING, INFLAMMATION, RECURRENT OBSTRUCTIVE JAUNDICE, BILE DUCT ULCERATION, DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION) ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, CHOLANGITIS IS LISTED AS A POTENTIAL COMPLICATION. INFORMATION RECEIVED IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT IT WAS THE COOK STENT THAT CONTRIBUTED TO THE EVENT. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT SUFFERED CHOLANGITIS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
DEVICE EVALUATION: THE EVO BILIARY STENT OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL '' A 17 YEARS RETROSPECTIVE STUDY ON MULTIPLE METAL STENTS FOR COMPLEX MALIGNANT HILAR BILIARY STRICTURES: SURVIVAL, STENTS PATENCY AND OUTCOMES OF RE-INTERVENTIONS FOR OCCLUDED METAL STENTS'' BOSKOSKI ET AL 2019. 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY; WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, NATICK, MA, USA), NITI-S (TAEWOONG MEDICAL INC., SEOUL, SOUTH KOREA) AND EVOLUTION (COOKENDOSCOPY, WINSTON-SALEM, NC, USA) SEMS WERE USED IN THIS STUDY. WE CANNOT CONFIRM THAT THE COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT SO THIS IS A CONSERVATIVE ASSESSMENT. THIS FILE CAPTURES 79 CASES OF CHOLANGITIS. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO BILIARY STENT DEVICE IS FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED PRIOR TO DISTRIBUTION ALL EVO BILIARY STENT DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER THE INSTRUCTIONS FOR USE, IFU0062-5, WHICH INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS STATES: POTENTIAL COMPLICATIONS ASSOCIATED WITH ECRP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, CHOLECYSTITIS, CHOLESTASIS, ASPIRATION, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST. ADDITIONAL COMPLICATIONS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM; PERFORATION; OBSTRUCTION OF THE PANCREATIC DUCT; STENT MIGRATION; STENT OCCLUSION; INGROWTH DUE TO TUMOR OR EXCESSIVE HYPERPLASTIC TISSUE; TUMOR OVERGROWTH; STENT MISPLACEMENT, PAIN, FEVER, NAUSEA, VOMITING, INFLAMMATION, RECURRENT OBSTRUCTIVE JAUNDICE, BILE DUCT ULCERATION, DEATH (OTHER THAN DUE TO NORMAL DISEASE PROGRESSION) ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, CHOLANGITIS IS LISTED AS A POTENTIAL COMPLICATION. INFORMATION RECEIVED IS NOT SUFFICIENT ENOUGH TO CONFIRM THAT IT WAS THE COOK STENT THAT CONTRIBUTED TO THE EVENT. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. PATIENT SUFFERED CHOLANGITIS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
LITERATURE REVIEW TITLE: 'A 17 YEARS RETROSPECTIVE STUDY ON MULTIPLE METAL STENTS FOR COMPLEX MALIGNANT HILAR BILIARY STRICTURES: SURVIVAL, STENTS PATENCY AND OUTCOMES OF RE-INTERVENTIONS FOR OCCLUDED METAL STENTS' BOSKOSKI ET AL 2019 OBJECTIVES OF THIS STUDY WERE EVALUATION OF SURVIVAL AND STENTS PATENCY AFTER PLACEMENT OF MULTIPLE SEMS FOR PALLIATION OF COMPLEX MHBS. WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, NATICK, MA, USA), NITI-S (TAEWOONG MEDICAL INC., SEOUL, SOUTH KOREA) AND EVOLUTION (COOKENDOSCOPY, WINSTON-SALEM, NC, USA) SEMS WERE USED IN THIS STUDY. PLEASE NOTE, AS 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY, WE CANNOT CONFIRM THAT A COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT. THIS IS A CONSERVATIVE ASSESSMENT SEVENTY-NINE (59%) PATIENTS DID NOT RESORT TO THE EMERGENCY DEPARTMENT FOR EVENTUAL ERCP WITH STENT REVISION. FURTHERMORE, AFTER TALKING WITH THE RELATIVES AND CONSULTING THE CERTIFICATES OF DEATH OF THE ITALIAN NATIONAL POPULATION REGISTRY THE REPORTED CAUSE OF DISEASE WAS 'PRIMARY DISEASE PROGRESSION', WHILE THE TERMS 'CHOLANGITIS' AND/OR RELATED SYMPTOMS WERE NOT MENTIONED OR REPORTED. ONE OF THE MAJOR LIMITATIONS OF THE PRESENT STUDY IS THE IMPOSSIBILITY TO KNOW WHETHER SEVENTY-NINE PATIENTS WHO DID NOT RESORT TO THE EMERGENCY DEPARTMENT FOR EVENTUAL ERCP WITH STENT REVISION DIED OF CHOLANGITIS OR NOT. AS REPORTED ABOVE, WE MADE ALL POSSIBLE EFFORTS TO BETTER UNDERSTAND THE CAUSE FOR DEATH IN THESE PATIENTS EVEN IF THE TERMS 'CHOLANGITIS' AND/OR RELATED SYMPTOMS WERE NOT MENTIONED NEITHER REPORTED IN THE DEATH CERTIFICATES. IT IS DIFFICULT TO BELIEVE THAT THESE PATIENTS OR AT LEAST A PART OF THEM DIED WITHOUT EPISODES OF CHOLANGITIS. THIS IS A CONSERVATIVE ASSESSMENT CLINICAL INPUT RECEIVED ON 24-JAN-2020: 'NO PROCEDURE-RELATED MORTALITY' MEANS THE MORTALITY WOULD BE DEVICE- OR DISEASES-RELATED (MOST LIKELY RELATED TO CANCER), SO IT DOES NOT RULE OUT THE POSSIBILITY OF DEVICE-RELATED (I.E., STENTS). I RED-MARKED 'YES' WHICH MEANS 'CHOLANGITIS' MIGHT BE RELATED TO COOK STENTS (AS WELL AS BOSTON SCIENTIFIC STENTS) DUE TO 'IT IS DIFFICULT TO BELIEVE THAT THESE PATIENTS OR AT LEAST A PART OF THEM DIED WITHOUT EPISODES OF CHOLANGITIS', AND 'CHOLANGITIS' IS A KNOWN COMPLICATION OF EVO-B (FC/UC/PC) IN OUR IFU. I ASSIGNED THE SEVERITY OF +4 BASED ON THE HARM OF 'CHOLANGITIS', NOT ON THE HARM OF 'DEATH'. IT WOULD BE VERY UNLIKELY THAT NO EPISODES OF CHOLANGITIS OCCURRED TO THE PATIENTS, HOWEVER, AS STATED IN THE ARTICLE, THERE WERE NO EVIDENCES INDICATING THAT COOK STENTS DIRECTLY CAUSED PATIENTS DEATH. IN FACT, ALMOST ALL PATIENTS DEATH WOULD HAVE BEEN ATTRIBUTED TO UNDERLYING MALIGNANT CONDITION. THEREFORE, I ASSIGNED 'YES' WITH A SEVERITY OF +4 FOR 'CHOLANGITIS', NOT FOR PATIENT¿S DEATH FILE IS BEING CREATED TO CAPTURE 79 CASES OF CHOLANGITIS.
SUPPLEMENT REPORT BEING SUBMITTED DUE TO CORRECTIONS MADE TO ANNEX E
CORRECTION REPORT REQUIRED DUE TO UPDATED ANNEX E CODE.
LITERATURE REVIEW TITLE: '' A 17 YEARS RETROSPECTIVE STUDY ON MULTIPLE METAL STENTS FOR COMPLEX MALIGNANT HILAR BILIARY STRICTURES: SURVIVAL, STENTS PATENCY AND OUTCOMES OF RE-INTERVENTIONS FOR OCCLUDED METAL STENTS'' BOSKOSKI ET AL 2019 OBJECTIVES OF THIS STUDY WERE EVALUATION OF SURVIVAL AND STENTS PATENCY AFTER PLACEMENT OF MULTIPLE SEMS FOR PALLIATION OF COMPLEX MHBS. WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, NATICK, MA, USA), NITI-S (TAEWOONG MEDICAL INC., SEOUL, SOUTH KOREA) AND EVOLUTION (COOKENDOSCOPY, WINSTON-SALEM, NC, USA) SEMS WERE USED IN THIS STUDY. PLEASE NOTE, AS 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY, WE CANNOT CONFIRM THAT A COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT. THIS IS A CONSERVATIVE ASSESSMENT SEVENTY-NINE (59%) PATIENTS DID NOT RESORT TO THE EMERGENCY DEPARTMENT FOR EVENTUAL ERCP WITH STENT REVISION. FURTHERMORE, AFTER TALKING WITH THE RELATIVES AND CONSULTING THE CERTIFICATES OF DEATH OF THE ITALIAN NATIONAL POPULATION REGISTRY THE REPORTED CAUSE OF DISEASE WAS ¿PRIMARY DISEASE PROGRESSION¿, WHILE THE TERMS ¿CHOLANGITIS¿ AND/OR RELATED SYMPTOMS WERE NOT MENTIONED OR REPORTED. ONE OF THE MAJOR LIMITATIONS OF THE PRESENT STUDY IS THE IMPOSSIBILITY TO KNOW WHETHER SEVENTY-NINE PATIENTS WHO DID NOT RESORT TO THE EMERGENCY DEPARTMENT FOR EVENTUAL ERCP WITH STENT REVISION DIED OF CHOLANGITIS OR NOT. AS REPORTED ABOVE, WE MADE ALL POSSIBLE EFFORTS TO BETTER UNDERSTAND THE CAUSE FOR DEATH IN THESE PATIENTS EVEN IF THE TERMS ¿CHOLANGITIS¿ AND/OR RELATED SYMPTOMS WERE NOT MENTIONED NEITHER REPORTED IN THE DEATH CERTIFICATES. IT IS DIFFICULT TO BELIEVE THAT THESE PATIENTS OR AT LEAST A PART OF THEM DIED WITHOUT EPISODES OF CHOLANGITIS. THIS IS A CONSERVATIVE ASSESSMENT. FILE IS BEING CREATED TO CAPTURE 79 CASES OF CHOLANGITIS.
INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. THIS IS A CONSERVATIVE ASSESSMENT - WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, NATICK, MA, USA), NITI-S (TAEWOONG MEDICAL INC., SEOUL, SOUTH KOREA) AND EVOLUTION (COOK ENDOSCOPY, WINSTON-SALEM, NC, USA) SEMS WERE USED IN THIS STUDY. PLEASE NOTE, AS 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY, WE CANNOT CONFIRM THAT A COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT. THE EXACT RPN IS UNKNOWN THEREFORE THE MOST LIKELY COMMON NAME FOR THIS IS FGE - COOK EVOLUTION BILIARY STENT AND K121430 IS THE MOST LIKELY 510 K #.
LITERATURE REVIEW TITLE: '' A 17 YEARS RETROSPECTIVE STUDY ON MULTIPLE METAL STENTS FOR COMPLEX MALIGNANT HILAR BILIARY STRICTURES: SURVIVAL, STENTS PATENCY AND OUTCOMES OF RE-INTERVENTIONS FOR OCCLUDED METAL STENTS'' BOSKOSKI ET AL 2019 OBJECTIVES OF THIS STUDY WERE EVALUATION OF SURVIVAL AND STENTS PATENCY AFTER PLACEMENT OF MULTIPLE SEMS FOR PALLIATION OF COMPLEX MHBS. WALLSTENT AND WALLFLEX (BOSTON SCIENTIFIC, NATICK, MA, USA), NITI-S (TAEWOONG MEDICAL INC., SEOUL, SOUTH KOREA) AND EVOLUTION (COOKENDOSCOPY, WINSTON-SALEM, NC, USA) SEMS WERE USED IN THIS STUDY. PLEASE NOTE, AS 3 DIFFERENT BRAND DEVICES WERE USED IN THIS STUDY, WE CANNOT CONFIRM THAT A COOK STENT WAS RELATED TO THIS SPECIFIC ADVERSE EVENT. THIS IS A CONSERVATIVE ASSESSMENT. SEVENTY-NINE (59%) PATIENTS DID NOT RESORT TO THE EMERGENCY DEPARTMENT FOR EVENTUAL ERCP WITH STENT REVISION. FURTHERMORE, AFTER TALKING WITH THE RELATIVES AND CONSULTING THE CERTIFICATES OF DEATH OF THE ITALIAN NATIONAL POPULATION REGISTRY THE REPORTED CAUSE OF DISEASE WAS ¿PRIMARY DISEASE PROGRESSION¿, WHILE THE TERMS ¿CHOLANGITIS¿ AND/OR RELATED SYMPTOMS WERE NOT MENTIONED OR REPORTED. ONE OF THE MAJOR LIMITATIONS OF THE PRESENT STUDY IS THE IMPOSSIBILITY TO KNOW WHETHER SEVENTY-NINE PATIENTS WHO DID NOT RESORT TO THE EMERGENCY DEPARTMENT FOR EVENTUAL ERCP WITH STENT REVISION DIED OF CHOLANGITIS OR NOT. AS REPORTED ABOVE, WE MADE ALL POSSIBLE EFFORTS TO BETTER UNDERSTAND THE CAUSE FOR DEATH IN THESE PATIENTS EVEN IF THE TERMS ¿CHOLANGITIS¿ AND/OR RELATED SYMPTOMS WERE NOT MENTIONED NEITHER REPORTED IN THE DEATH CERTIFICATES. IT IS DIFFICULT TO BELIEVE THAT THESE PATIENTS OR AT LEAST A PART OF THEM DIED WITHOUT EPISODES OF CHOLANGITIS. THIS IS A CONSERVATIVE ASSESSMENT. FILE IS BEING CREATED TO CAPTURE 79 CASES OF CHOLANGITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105340 | UNKNOWN | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |