BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 10492746 · Received September 4, 2020

    Report

    Report Number
    3001845648-2020-00546
    Event Type
    Injury
    Date Received
    September 4, 2020
    Date of Event
    April 6, 2020
    Report Date
    January 25, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 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) (REPORT REFERENCE NUMBER 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) (REPORT REFERENCE NUMBER 3001845648-2020-00546) CREATED TO CAPTURE THE 13 STENT MIGRATIONS OF THE OFF-LABEL USE ¿INSIDE STENT¿ (MODIFIED COTTON-LEUNG BILIARY STENT.) (B)(6) (REPORT REFERENCE NUMBER 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) (REPORT REFERENCE NUMBER 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) (REPORT REFERENCE NUMBER 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) (REPORT REFERENCE NUMBER 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) (REPORT REFERENCE NUMBER 3001845648-2020-00549) TO CAPTURE THE 4 CASES OF OCCLUSION OF THE ¿OUTSIDE STENT¿ (COTTON-LEUNG BILIARY STENT.) (ON LABEL USE) (B)(6) (REPORT REFERENCE NUMBER 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) (REPORT REFERENCE NUMBER 3001845648-2021-00161) CREATED FOR THE USER ERROR FOR EXCEEDING THE MAXIMUM 3 MONTH INDWELL PERIOD WITH NO ADVERSE EFFECTS FOR THE ¿OUTSIDE¿ STENT LAB EVALUATION ¿ N/A. IMAGE REVIEW ¿ N/A. 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 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 (IFU0045-7 AND 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, (IFU0045-7 AND 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 POTENTIAL 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 STENT MIGRATIONS OF THE OFF-LABEL USE OF THE ¿INSIDE STENT¿. STENT MIGRATION OCCURRED IN 13 OF THE INSIDE STENT SESSIONS AND NO OUTSIDE STENTS. THE POTENTIAL USER ERROR FOR EXCEEDING THE MAXIMUM INDWELL PERIOD WAS ALSO NOTED HERE AS THE MEDIAN TIME TO STENT MIGRATION WAS 88 DAYS (RANGE; 13¿515). 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 WAS ALSO NOTED AS PER THE INSTRUCTIONS FOR USE, STENT MIGRATION IS A KNOWN POTENTIAL COMPLICATION. 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.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EXACT RPN IS UNKNOWN BUT BASED ON THE DEVICE NAME OF COTTON-LEUNG BILIARY STENT, THE TWO POSSIBLE PMA 510K NUMBERS ARE K851962 / K851962. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    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. STENT MIGRATION OCCURRED IN 13 OF THE INSIDE STENT SESSIONS (16%), WHEREAS NONE OF THE OUTSIDE STENT SESSIONS (0%). THE MEDIAN TIME TO STENT MIGRATION WAS 88 DAYS (RANGE; 13¿515) FOR INSIDE STENT. THIS FILE IS CAPTURING THE 13 STENT MIGRATIONS OF THE INSIDE STENT, THIS IS RELATED TO THE OFF-LABEL USE OF ALTERING THE SHAPE OF THE STENT AS DESCRIBED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959125 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