COTTON-LEUNG BILIARY STENT
Report
- Report Number
- 3001845648-2020-00547
- Event Type
- Injury
- Date Received
- September 4, 2020
- Date of Event
- April 6, 2020
- Report Date
- February 21, 2023
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE EXACT RPN IS UNKNOWN BUT BASED ON THE DEVICE NAME OF COTTON-LEUNG BILIARY STENT, THE TWO POSSIBLE 510K NUMBERS ARE K851962 / K851962. DEVICE EVALUATION THE COTTON-LEUNG SOFT FLEX BILIARY STENT OF UNKNOWN LOT NUMBER AND RPN INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. ¿ENDOSCOPIC STENT PLACEMENT ABOVE THE SPHINCTER OF ODDI FOR BILIARY STRICTURES AFTER LIVING DONOR LIVER TRANSPLANTATION". THE BELOW FILES WERE OPENED AS RESULT OF THIS PAPER: 307065 CREATED TO CAPTURE THE 28 CASES OF THE OFF-LABEL USE OF THE ¿INSIDE STENT¿ (MODIFIED COTTON-LEUNG BILIARY STENT.) 307068 CREATED TO CAPTURE THE 13 STENT MIGRATIONS OF THE OFF-LABEL USE ¿INSIDE STENT¿ (MODIFIED COTTON-LEUNG BILIARY STENT.) 307070 CREATED TO CAPTURE THE 13 CASES STENT OCCLUSION, 3 CASES OF PANCREATITIS AND 14 CASES OF STONE FORMATION OF THE OFF-LABEL USE OF THE ¿INSIDE STENT¿ (MODIFIED COTTON-LEUNG BILIARY STENT.) 307072 CREATED TO CAPTURE 6 CASES OF CHOLANGITIS WITH THE OFF-LABEL USE OF THE ¿INSIDE STENT¿ (MODIFIED COTTON-LEUNG BILIARY STENT.) 307071 CREATED TO CAPTURE 3 CASES PANCREATITIS OF WITH THE USE OF THE ¿OUTSIDE STENT¿ (COTTON-LEUNG BILIARY STENT.) (ON LABEL USE) 307073 CREATED TO CAPTURE THE 3 CASES OF STONE FORMATION OF THE ¿OUTSIDE STENT¿ (COTTON-LEUNG BILIARY STENT.) (ON LABEL USE) 307074 CREATED TO CAPTURE THE 4 CASES OF OCCLUSION OF THE ¿OUTSIDE STENT¿ (COTTON-LEUNG BILIARY STENT.) (ON LABEL USE) 320640 CREATED FOR CASES OF OCCLUSION ASSOCIATED WITH USER ERROR FOR EXCEEDING THE MAXIMUM 3 MONTH INDWELL PERIOD FOR THE ¿OUTSIDE¿ STENTS. 320641 CREATED FOR THE USER ERROR FOR EXCEEDING THE MAXIMUM 3 MONTH INDWELL PERIOD WITH NO ADVERSE EFFECTS FOR THE ¿OUTSIDE¿ STENT. DOCUMENT REVIEW AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL COTTON-LEUNG SOFT FLEX BILIARY STENT DEVICES 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. IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE ( IFU0120-3 ) ¿TO DRAIN OBSTRUCTED BILIARY DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ THE CUSTOMER IS NOTIFIED AS PER INSTRUCTIONS FOR USE, ( IFU0120-3 ) WHICH ACCOMPANIES THIS DEVICE, IN THE POTENTIAL COMPLICATIONS SECTION: ¿THOSE ASSOCIATED WITH ERCP INCLUDE BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST¿ AND ¿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.¿ AND IN THE PRECAUTIONS SECTION THE DEVICE ¿SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED.¿ AS PER THE INFORMATION REPORTED BILIARY STENTS WERE PLACED IN 87 SESSIONS: 77 INSIDE SESSIONS AND 10 OUTSIDE SESSIONS. AS BOTH A COMPETITOR STENT AND A COOK DEVICE IS MENTIONED AS USED, FOR THE PURPOSE OF THE WRITE UP A WORST-CASE APPROACH WILL BE TAKEN AND THE COOK DEVICE (COTTON-LEUNG BILIARY STENT) WILL BE ASSUMED AS USED IN EACH CASE. THE ¿OUTSIDE¿ STENT PLACEMENT WAS NOTED AS ON LABEL CONVENTIONAL USE OF THE DEVICE AS THE STENT WAS PLACED ACROSS THE SPHINCTER OF ODDI, WITH THEIR DISTAL END EXPOSED INTO THE DUODENUM. THE ¿INSIDE¿ STENTS WERE NOTED AS PLACED OFF LABEL AND HAD A USER ERROR ASSOCIATED WITH EACH AS THEY WERE MODIFIED WITH A DISTAL FLAP REMOVED AND A NYLON THREAD ATTACHED. THE USER ERROR FOR EXCEEDING THE MAXIMUM IN DWELL PERIOD IS ALSO NOTED HERE AS IT IS REPORTED THAT STENT EXCHANGE/REMOVAL WAS SCHEDULED EVERY 6 TO 12 MONTHS OR EARLIER IF OCCLUSION/ MIGRATION OCCURRED AND THAT THE MEDIAN PATENCY PERIOD OF INSIDE STENT WAS 222 DAYS (7.4 MONTHS) AND OUTSIDE STENT WAS 99 DAYS (3.3 MONTHS). THE ADVERSE EVENTS NOTED WITH BOTH ¿INSIDE¿ AND ¿OUTSIDE¿ STENTS OF MIGRATION, OCCLUSION, STONE FORMATION, PANCREATITIS AND CHOLANGITIS WILL BE DEALT WITH IN SEPARATE FILES (PR307068, PR307070, PR307072, PR307071, PR307073, PR307074, PR320640). THIS FILE WILL DEAL WITH THE 13 CASES STENT OCCLUSION, 3 CASES OF PANCREATITIS AND 14 CASES OF STONE FORMATION OF THE OFF-LABEL USE OF THE ¿INSIDE STENT¿ STENT OCCLUSION OCCURRED IN 13 (16%) OF THE INSIDE STENT SESSIONS. THE POTENTIAL USER ERROR FOR EXCEEDING THE MAXIMUM INDWELL PERIOD WAS ALSO NOTED HERE AS THE MEDIAN TIME TO STENT OCCLUSION WAS 175 DAYS (36¿425) FOR INSIDE STENT. STONE FORMATION WAS OBSERVED IN 14 CASES OF USE OF INSIDE STENT. BILIARY STONES WERE SMALL AND SUCCESSFULLY REMOVED ENDOSCOPICALLY EXCEPT ONE CASE REQUIRING EST. IT WAS NOTED IN THE PAPER THAT ¿WHEN THE PATENT PERIOD OF THE INSIDE STENT GETS LONGER, INDWELLING STENTS CAN CAUSE STENT-STONE COMPLEXES¿. EARLY COMPLICATIONS OF PANCREATITIS WERE NOTED WITH BOTH THE INSIDE AND OUTSIDE STENTS. AS THE INFORMATION REPORTED NOTES 6 SESSIONS LEADING TO PANCREATITIS AND ONLY FIGURES OF 3 AND 1 MENTIONED WITH THE INSIDE AND OUTSIDE STENT, RESPECTIVELY, FOR THE PURPOSE OF THIS INVESTIGATION A WORST CASE APPROACH WAS TAKEN OF 3 STENT FOR INSIDE AND 3 FOR OUTSIDE LEADING TO PANCREATITIS (REF ATT. CLINICAL INPUT PANCREATITIS CHOLANGITIS). IT WAS NOTED THAT ALL PATIENTS IMPROVED WITH CONSERVATIVE TREATMENT. THERE WERE NO SEVERE ADVERSE EVENTS. ROOT CAUSE REVIEW A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. WHERE USE OF THE DEVICE IN THIS PROCEDURE IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEING TESTED IN A CLINICAL SETTING. IT CAN BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE THAT OBSTRUCTION OF COMMON BILE DUCT AND PANCREATITIS ARE KNOWN POTENTIAL COMPLICATIONS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, BILIARY STRICTURES WERE SUCCESSFULLY TREATED IN 14 PATIENTS WHERE STENTING WAS POSSIBLE. BILIARY STRICTURES IMPROVED IN 7 PATIENTS ON REPEAT ERC, WHO THEREFORE HAD THEIR STENTS REMOVED. STENT REPLACEMENT WAS PERFORMED EVERY 6 TO 12 MONTHS FOR THE OTHER 7 PATIENTS. IT WAS NOTED THAT ALL PATIENTS IMPROVED WITH CONSERVATIVE TREATMENT. THERE WERE NO SEVERE ADVERSE EVENTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE EXACT RPN IS UNKNOWN BUT BASED ON THE DEVICE NAME OF COTTON-LEUNG BILIARY STENT, THE TWO POSSIBLE 510K NUMBERS ARE K851962 / K851962. DEVICE EVALUATION: THE COTTON-LEUNG SOFT FLEX BILIARY STENT OF UNKNOWN LOT NUMBER AND RPN INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE. ¿ENDOSCOPIC STENT PLACEMENT ABOVE THE SPHINCTER OF ODDI FOR BILIARY STRICTURES AFTER LIVING DONOR LIVER TRANSPLANTATION". THE BELOW FILES WERE OPENED AS RESULT OF THIS PAPER: (B)(6) (3001845648-2020-00555) CREATED TO CAPTURE THE 28 CASES OF THE OFF-LABEL USE OF THE ¿INSIDE STENT¿ (MODIFIED COTTON-LEUNG BILIARY STENT.) (B)(6)(3001845648-2020-00546) CREATED TO CAPTURE THE 13 STENT MIGRATIONS OF THE OFF-LABEL USE ¿INSIDE STENT¿ (MODIFIED COTTON-LEUNG BILIARY STENT.) (B)(6) (3001845648-2020-00547) CREATED TO CAPTURE THE 13 CASES STENT OCCLUSION, 3 CASES OF PANCREATITIS AND 14 CASES OF STONE FORMATION OF THE OFF-LABEL USE OF THE ¿INSIDE STENT¿ (MODIFIED COTTON-LEUNG BILIARY STENT.) (B)(6) (3001845648-2020-00557) CREATED TO CAPTURE 6 CASES OF CHOLANGITIS WITH THE OFF-LABEL USE OF THE ¿INSIDE STENT¿ (MODIFIED COTTON-LEUNG BILIARY STENT.) (B)(6) (3001845648-2020-00556) CREATED TO CAPTURE 3 CASES PANCREATITIS OF WITH THE USE OF THE ¿OUTSIDE STENT¿ (COTTON-LEUNG BILIARY STENT.) (ON LABEL USE) (B)(6) (3001845648-2020-00548) CREATED TO CAPTURE THE 3 CASES OF STONE FORMATION OF THE ¿OUTSIDE STENT¿ (COTTON-LEUNG BILIARY STENT.) (ON LABEL USE) (B)(6) (3001845648-2020-00549) CREATED TO CAPTURE THE 4 CASES OF OCCLUSION OF THE ¿OUTSIDE STENT¿ (COTTON-LEUNG BILIARY STENT.) (ON LABEL USE) (B)(6) (3001845648-2021-00162) CREATED FOR CASES OF OCCLUSION ASSOCIATED WITH USER ERROR FOR EXCEEDING THE MAXIMUM 3 MONTH INDWELL PERIOD FOR THE ¿OUTSIDE¿ STENTS. (B)(6) (3001845648-2021-00161) CREATED FOR THE USER ERROR FOR EXCEEDING THE MAXIMUM 3 MONTH INDWELL PERIOD WITH NO ADVERSE EFFECTS FOR THE ¿OUTSIDE¿ STENT. DOCUMENT REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL COTTON-LEUNG SOFT FLEX BILIARY STENT DEVICES 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. IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE ( IFU0120-3 ) ¿TO DRAIN OBSTRUCTED BILIARY DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ THE CUSTOMER IS NOTIFIED AS PER INSTRUCTIONS FOR USE, ( IFU0120-3 ) WHICH ACCOMPANIES THIS DEVICE, IN THE POTENTIAL COMPLICATIONS SECTION: ¿THOSE ASSOCIATED WITH ERCP INCLUDE BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST¿ AND ¿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.¿ AND IN THE PRECAUTIONS SECTION THE DEVICE ¿SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED.¿ AS PER THE INFORMATION REPORTED BILIARY STENTS WERE PLACED IN 87 SESSIONS: 77 INSIDE SESSIONS AND 10 OUTSIDE SESSIONS. AS BOTH A COMPETITOR STENT AND A COOK DEVICE IS MENTIONED AS USED, FOR THE PURPOSE OF THE WRITE UP A WORST-CASE APPROACH WILL BE TAKEN AND THE COOK DEVICE (COTTON-LEUNG BILIARY STENT) WILL BE ASSUMED AS USED IN EACH CASE. THE ¿OUTSIDE¿ STENT PLACEMENT WAS NOTED AS ON LABEL CONVENTIONAL USE OF THE DEVICE AS THE STENT WAS PLACED ACROSS THE SPHINCTER OF ODDI, WITH THEIR DISTAL END EXPOSED INTO THE DUODENUM. THE ¿INSIDE¿ STENTS WERE NOTED AS PLACED OFF LABEL AND HAD A USER ERROR ASSOCIATED WITH EACH AS THEY WERE MODIFIED WITH A DISTAL FLAP REMOVED AND A NYLON THREAD ATTACHED. THE USER ERROR FOR EXCEEDING THE MAXIMUM IN DWELL PERIOD IS ALSO NOTED HERE AS IT IS REPORTED THAT STENT EXCHANGE/REMOVAL WAS SCHEDULED EVERY 6 TO 12 MONTHS OR EARLIER IF OCCLUSION/ MIGRATION OCCURRED AND THAT THE MEDIAN PATENCY PERIOD OF INSIDE STENT WAS 222 DAYS (7.4 MONTHS) AND OUTSIDE STENT WAS 99 DAYS (3.3 MONTHS). THE ADVERSE EVENTS NOTED WITH BOTH ¿INSIDE¿ AND ¿OUTSIDE¿ STENTS OF MIGRATION, OCCLUSION, STONE FORMATION, PANCREATITIS AND CHOLANGITIS WILL BE DEALT WITH IN SEPARATE FILES ((B)(4)). THIS FILE WILL DEAL WITH THE 13 CASES STENT OCCLUSION, 3 CASES OF PANCREATITIS AND 14 CASES OF STONE FORMATION OF THE OFF-LABEL USE OF THE ¿INSIDE STENT¿ STENT OCCLUSION OCCURRED IN 13 (16%) OF THE INSIDE STENT SESSIONS. THE POTENTIAL USER ERROR FOR EXCEEDING THE MAXIMUM INDWELL PERIOD WAS ALSO NOTED HERE AS THE MEDIAN TIME TO STENT OCCLUSION WAS 175 DAYS (36¿425) FOR INSIDE STENT. STONE FORMATION WAS OBSERVED IN 14 CASES OF USE OF INSIDE STENT. BILIARY STONES WERE SMALL AND SUCCESSFULLY REMOVED ENDOSCOPICALLY EXCEPT ONE CASE REQUIRING EST. IT WAS NOTED IN THE PAPER THAT ¿WHEN THE PATENT PERIOD OF THE INSIDE STENT GETS LONGER, INDWELLING STENTS CAN CAUSE STENT-STONE COMPLEXES¿. EARLY COMPLICATIONS OF PANCREATITIS WERE NOTED WITH BOTH THE INSIDE AND OUTSIDE STENTS. AS THE INFORMATION REPORTED NOTES 6 SESSIONS LEADING TO PANCREATITIS AND ONLY FIGURES OF 3 AND 1 MENTIONED WITH THE INSIDE AND OUTSIDE STENT, RESPECTIVELY, FOR THE PURPOSE OF THIS INVESTIGATION A WORST CASE APPROACH WAS TAKEN OF 3 STENT FOR INSIDE AND 3 FOR OUTSIDE LEADING TO PANCREATITIS (REF ATT. CLINICAL INPUT PANCREATITIS CHOLANGITIS). IT WAS NOTED THAT ALL PATIENTS IMPROVED WITH CONSERVATIVE TREATMENT. THERE WERE NO SEVERE ADVERSE EVENTS. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THE OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED, IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. WHERE USE OF THE DEVICE IN THIS PROCEDURE IS NOT A STATED USE AS PER THE IFU AND THEREFORE HAS NOT BEING TESTED IN A CLINICAL SETTING. IT CAN BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE THAT OBSTRUCTION OF COMMON BILE DUCT AND PANCREATITIS ARE KNOWN POTENTIAL COMPLICATIONS. SUMMARY: COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, BILIARY STRICTURES WERE SUCCESSFULLY TREATED IN 14 PATIENTS WHERE STENTING WAS POSSIBLE. BILIARY STRICTURES IMPROVED IN 7 PATIENTS ON REPEAT ERC, WHO THEREFORE HAD THEIR STENTS REMOVED. STENT REPLACEMENT WAS PERFORMED EVERY 6 TO 12 MONTHS FOR THE OTHER 7 PATIENTS. IT WAS NOTED THAT ALL PATIENTS IMPROVED WITH CONSERVATIVE TREATMENT. THERE WERE NO SEVERE ADVERSE EVENTS. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
THE EXACT RPN IS UNKNOWN BUT BASED ON THE DEVICE NAME OF COTTON-LEUNG BILIARY STENT, THE TWO POSSIBLE 510K NUMBERS ARE K851962 / K851962. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A CORRECTION OF THE INVESTIGATION IMDRF CODES.
SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.
THIS COMPLAINT WAS UPDATED ON THE 26-JAN-2021 AND IS NOW ALSO CAPTURING 3 CASES OF PANCREATITIS RELATED TO THE INSIDE STENT AS THIS OCCURRED OFF LABEL, THESE UPDATES WERE MADE TO ALIGN WITH COOK IRELAND COMPLAINTS PROCESS NO NEW INFORMATION WAS RECEIVED. EVENT DESCRIPTION AND PATIENT CODES UPDATED. KOIZUMI ET AL. 2020 ¿ENDOSCOPIC STENT PLACEMENT ABOVE THE SPHINCTER OF ODDI FOR BILIARY STRICTURES AFTER LIVING DONOR LIVER TRANSPLANTATION¿ SIXTEEN CONSECUTIVE PATIENTS WITH A MEDIAN AGE OF 55.5 YEARS (RANGE, 36¿67 YEARS) SUFFERING FROM BILIARY STRICTURES AFTER LDLT WITH DUCT-TO-DUCT BILIARY RECONSTRUCTION FOR END-STAGE LIVER DISEASE OR ACUTE LIVER FAILURE AT OUR HOSPITAL BETWEEN 2004 AND 2016 WERE ELIGIBLE. ANASTOMOTIC BILIARY STRICTURES WERE DIAGNOSED BY ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERC). OUTSIDE STENTS WERE PLACED ACROSS THE SPHINCTER OF ODDI, WITH THEIR DISTAL END EXPOSED INTO THE DUODENUM. INSIDE STENTS BEING PLACED ABOVE THE SPHINCTER OF ODDI (FIG. 1B, E). ENDOSCOPIC SPHINCTEROTOMY (EST) WAS NOT PERFORMED FOR BOTH METHODS AT INITIAL ATTEMPT. THE SHAPE OF A 7-10FR PLASTIC STENT FLEXIMA; BOSTON SCIENTIFIC JAPAN, TOKYO, JAPAN. COTTON-LEUNG SOF-FLEX BILIARY STENT; COOK JAPAN, JAPAN. THROUGHPASS; GADELIUS MEDICAL, TOKYO, JAPAN) WAS MODIFIED AS AN INSIDE STENT. THE DISTAL FLAP OF THE STENT WAS REMOVED BUT INSTEAD A NYLON THREAD WAS ATTACHED TO THE DISTAL SIDE HOLE BEYOND THE DUODENAL PAPILLA TO FACILITATE RETRIEVAL OF THE INSIDE STENT, AS PREVIOUSLY REPORTED. IN THIS STUDY, WE ANALYZED A TOTAL OF 98 ERC SESSIONS FOR 16 PATIENTS UNDERGOING ENDOSCOPIC TREATMENT OF BILIARY STRICTURE AFTER LDLT WITH DUCT-TO-DUCT BILIARY RECONSTRUCTION. BILIARY STENTS WERE PLACED IN 87 SESSIONS: 77 INSIDE SESSIONS AND 10 OUTSIDE SESSIONS. + BELOW INDIVIDUAL COMPLAINT INFO; #3. STENT OCCLUSION WAS DEFINED BY ERC WHEN THE STENT ACROSS THE BILIARY STRICTURE WAS SUSPICIOUS IN THE PRESENCE OF JAUNDICE, FEVER, ABNORMAL BILIARY ENZYMES AND ABNORMAL BILIARY FINDINGS ON ABDOMINAL IMAGING. STENT OCCLUSION OCCURRED IN 13 (16%) AND 4 (40%) OF THE INSIDE STENT AND THE OUTSIDE STENT SESSIONS, RESPECTIVELY. AMONG 17 STENT OCCLUSIONS, THE MEDIAN TIME TO STENT OCCLUSION WAS 175 DAYS (RANGE; 36¿425) FOR INSIDE STENT AND 138 DAYS (MEDIAN; 76¿158) FOR OUTSIDE STENT. STONE FORMATION WAS OBSERVED IN 14 (18%) OF THE INSIDE STENT AND 3 (30%) OF THE OUTSIDE STENT. BILIARY STONES WERE SMALL AND SUCCESSFULLY REMOVED ENDOSCOPICALLY EXCEPT ONE CASE REQUIRING EST. THIS FILE WAS CREATED TO CAPTURE THE 13 CASES STENT OCCLUSION, 3 CASES OF PANCREATITIS AND 14 CASES OF STONE FORMATION OF THE INSIDE STENT, THIS IS RELATED TO THE OFF-LABEL USE OF ALTERING THE SHAPE OF THE STENT AS DESCRIBED ABOVE. STENT OCCLUSION, PANCREATITIS AND STONE FORMATION OF THE OUTSIDE STENT HAVE BEEN CAPTURED IN SEPARATE FILES AS THESE ARE NOT RELATED TO OFF LABEL USE.
THE EXACT RPN IS UNKNOWN BUT BASED ON THE DEVICE NAME OF COTTON-LEUNG BILIARY STENT, THE TWO POSSIBLE 510K NUMBERS ARE K851962 / K851962. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
KOIZUMI ET AL. 2020 ¿ENDOSCOPIC STENT PLACEMENT ABOVE THE SPHINCTER OF ODDI FOR BILIARY STRICTURES AFTER LIVING DONOR LIVER TRANSPLANTATION¿. SIXTEEN CONSECUTIVE PATIENTS WITH A MEDIAN AGE OF 55.5 YEARS (RANGE, 36¿67 YEARS) SUFFERING FROM BILIARY STRICTURES AFTER LDLT WITH DUCT-TO-DUCT BILIARY RECONSTRUCTION FOR END-STAGE LIVER DISEASE OR ACUTE LIVER FAILURE AT OUR HOSPITAL BETWEEN 2004 AND 2016 WERE ELIGIBLE. ANASTOMOTIC BILIARY STRICTURES WERE DIAGNOSED BY ENDOSCOPIC RETROGRADE CHOLANGIOGRAPHY (ERC). OUTSIDE STENTS WERE PLACED ACROSS THE SPHINCTER OF ODDI, WITH THEIR DISTAL END EXPOSED INTO THE DUODENUM. INSIDE STENTS BEING PLACED ABOVE THE SPHINCTER OF ODDI (FIG. 1B, E). ENDOSCOPIC SPHINCTEROTOMY (EST) WAS NOT PERFORMED FOR BOTH METHODS AT INITIAL ATTEMPT. THE SHAPE OF A 7-10FR PLASTIC STENT FLEXIMA; BOSTON SCIENTIFIC JAPAN, TOKYO, JAPAN. COTTON-LEUNG SOF-FLEX BILIARY STENT; COOK JAPAN, JAPAN. THROUGHPASS; GADELIUS MEDICAL, TOKYO, JAPAN) WAS MODIFIED AS AN INSIDE STENT. THE DISTAL FLAP OF THE STENT WAS REMOVED BUT INSTEAD A NYLON THREAD WAS ATTACHED TO THE DISTAL SIDE HOLE BEYOND THE DUODENAL PAPILLA TO FACILITATE RETRIEVAL OF THE INSIDE STENT, AS PREVIOUSLY REPORTED. IN THIS STUDY, WE ANALYZED A TOTAL OF 98 ERC SESSIONS FOR 16 PATIENTS UNDERGOING ENDOSCOPIC TREATMENT OF BILIARY STRICTURE AFTER LDLT WITH DUCT-TO-DUCT BILIARY RECONSTRUCTION. BILIARY STENTS WERE PLACED IN 87 SESSIONS: 77 INSIDE SESSIONS AND 10 OUTSIDE SESSIONS. + BELOW INDIVIDUAL COMPLAINT INFO; #3 STENT OCCLUSION WAS DEFINED BY ERC WHEN THE STENT ACROSS THE BILIARY STRICTURE WAS SUSPICIOUS IN THE PRESENCE OF JAUNDICE, FEVER, ABNORMAL BILIARY ENZYMES AND ABNORMAL BILIARY FINDINGS ON ABDOMINAL IMAGING. STENT OCCLUSION OCCURRED IN 13 (16%) AND 4 (40%) OF THE INSIDE STENT AND THE OUTSIDE STENT SESSIONS, RESPECTIVELY. AMONG 17 STENT OCCLUSIONS, THE MEDIAN TIME TO STENT OCCLUSION WAS 175 DAYS (RANGE; 36¿425) FOR INSIDE STENT AND 138 DAYS (MEDIAN; 76¿158) FOR OUTSIDE STENT. STONE FORMATION WAS OBSERVED IN 14 (18%) OF THE INSIDE STENT AND 3 (30%) OF THE OUTSIDE STENT. BILIARY STONES WERE SMALL AND SUCCESSFULLY REMOVED ENDOSCOPICALLY EXCEPT ONE CASE REQUIRING EST. THIS FILE WAS CREATED TO CAPTURE THE 13 CASES STENT OCCLUSION AND 14 CASES OF STONE FORMATION OF THE INSIDE STENT, THIS IS RELATED TO THE OFF-LABEL USE OF ALTERING THE SHAPE OF THE STENT AS DESCRIBED ABOVE. STENT OCCLUSION AND STONE FORMATION OF THE OUTSIDE STENT HAVE BEEN CAPTURED IN SEPARATE FILES AS THESE ARE NOT RELATED TO OFF LABEL USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 957491 | COTTON-LEUNG BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Unknown | Required Intervention |