Flexima™ Biliary M00539280Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729162599), received between Apr 24, 2017 and Feb 24, 2026 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED IN THE GALLBLADDER DURING A GALLSTONE LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PLASTIC STENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 25, 2026: IT WAS REPORTED THAT THE DEVICE WAS ATTEMPTED TO BE IMPLANTED IN THE GALLBLADDER FOR STONES TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437264 ↗
• MalfunctionAug 14, 2025Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED TO TREAT A STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PRODUCT COULD NOT BE DEPLOYED DUE TO A FRACTURE OF THE WIRE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED ON AUGUST 12, 2025. IT WAS REPORTED THAT IT WAS THE SUTURE THAT WAS FRACTURED. ADDITIONALLY, THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. ALSO, THE GUIDEWIRE WAS INSIDE THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE IFU, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED." FURTHERMORE, IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE IFU, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION. THE USER DID NOT FOLLOW THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22809580 ↗
• MalfunctionJul 22, 2025Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE BILIARY TRACT DURING A BILIARY STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6), 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE IFU, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED." NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569972 ↗
• MalfunctionJun 5, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Positioning Failure; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE GALLBLADDER TO TREAT PAIN DURING A CHOLEDOCHOLITHIASIS PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE RELEASED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE STENT BARB WAS TORN. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152692 ↗
• MalfunctionMar 25, 2025Positioning Failure; Defective Device; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Defective Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A COMMON BILE DUCT STONE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE RO MARKER BAND WAS PRESENT ON THE DELIVERY SYSTEM. HOWEVER, IT WAS NOT CLEARLY VISIBLE UNDER XRAY, AND THE STENT COULD NOT BE DEPLOYED. ANOTHER FLEXIMA BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE STENT WAS BROKEN. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689594 ↗
• MalfunctionJan 2, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE IMPLANTED IN THE BILIARY TRACT FOR DRAINAGE OF BILE AND REDUCTION OF BILIRUBIN DURING A STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. ANOTHER FLEXIMA BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060426 ↗
• MalfunctionDec 21, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED IN THE DUODENAL PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE STENT WAS NOT SMOOTH. THE PHYSICIAN FELT RESISTANCE WHEN RETRACTING THE STENT, SUBSEQUENTLY, THE STENT WAS NOT DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THE GUIDE CATHETER WAS DETACHED/SEPARATED FROM THE PUSH CATHETER. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375304 ↗
• MalfunctionMay 15, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA BILIARY STENT WAS ATTEMPTED TO BE PLACED IN THE BILIARY TRACT, FOR BILIARY DILATION ON (B)(6) 2023. DURING THE PROCEDURE, INSIDE THE PATIENT, IT WAS NOTICED THAT THE GUIDE CATHETER DETACHED BEFORE THE PHYSICIAN WAS ABLE TO RETRACT THE PULL WIRE TO DEPLOY THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934720 ↗
• InjurySep 30, 2022Break; Positioning Failure; Use of Device Problem; Break; Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE FOR BILE DRAINAGE IN THE BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER BROKE. THE BROKEN PIECE OF GUIDE CATHETER WAS REMOVED BY A PAIR OF FORCEPS AND ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509890 ↗
• MalfunctionAug 15, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING PANCREATIC CYSTIC LESION PROCEDURE IN THE BILIARY TRACT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THE GUIDE CATHETER DETACHED/SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223263 ↗
• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, PERFORMED ON (B)(6) 2022. DURING UNPACKING, THE STENT WAS FOUND FRACTURED. ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE TOUHY BORST WAS DETACHED/SEPARATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14470247 ↗
• MalfunctionMar 1, 2022Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE STENT RELEASE IT COULDN'T BE DONE CORRECTLY AND THE SHEATH DEFORMED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13639909 ↗
• MalfunctionFeb 8, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, WHEN THE FLEXIMA BILIARY STENT WAS TRIED TO IMPLANT INTO THE BILE DUCT, IT WAS FOUND THAT THE TIP OF THE STENT BECAME BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481995 ↗
• MalfunctionNov 30, 2021Break; Positioning Failure; Entrapment of Device; Break; Positioning Failure; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILIARY TRACT, PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED THE TO DEPLOY THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER BONDED TO THE GUIDEWIRE. THE STENT FAILED TO DEPLOY AND WAS NOTICED TO BE FRACTURED. THE BROKEN STENT WAS COMPLETELY REMOVED FROM THE PATIENT IN ONE PIECE AND ANOTHER FLEXIMA BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12894358 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED A DURING BILIARY STENT IMPLANTATION IN THE COMMON BILE DUCT PERFOMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE STENT WAS KINKED AND DEFORMED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED/ SEPARATED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10135828 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A BILIARY STENT IMPLANTATION IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE STENT WAS KINKED AND DEFORMED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED/SEPARATED, THEREFORE, THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10134877 ↗
• MalfunctionMar 9, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PRODUCT PRESENTED DEFECTIVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; GUIDE CATHETER BREAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806381 ↗
• MalfunctionAug 23, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY STENT WAS USED DURING A BILIARY STENTING PROCEDURE IN THE BILIARY DUCTS PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDE CATHETER BROKE INTO TWO PIECES WHEN THE PHYSICIAN WAS DEPLOYING THE STENT AND RETRACTING THE GUIDE CATHETER. AFTER RELEASING THE STENT, THE INNER GUIDE CATHETER STOPPED MOVING SMOOTHLY IN RETRACTING, AND IT ELONGATED UNTIL IT BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS STABLE. ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING RETRIEVAL OF THE BROKEN GUIDE CATHETER HAVE BEEN UNSUCCESSFUL TO DATE. IF ANY ADDITIONAL RELEVANT INFORMATION IS REPORTED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8927779 ↗
• MalfunctionMar 27, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILI PRELOADED STENT USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FLEXIMA BILI PRELOADED STENT WAS USED FOR DRAINAGE, IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS BROKEN AND STENT COULD NOT REACH THE LESION. THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA BILI PRELOADED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457422 ↗
• InjuryJan 4, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA BILIARY PRELOADED STENT WAS USED DURING A BILIARY STENT IMPLANT PROCEDURE FOR A POST LIVER TRANSPLANT STRICTURE, WHICH WAS PERFORMED ON (B)(6), 2017. ACCORDING TO THE PHYSICIAN, WHEN THEY DEPLOYED THE BILIARY STENT INSIDE THE PATIENT¿S DUCT, IT DID NOT SEPARATE FROM THE CATHETER DUE TO THE GUIDE CATHETER DETACHING AND ¿GETTING STUCK¿ IN THE STENT. THE PHYSICIAN SENT THE PATIENT TO SURGERY WHERE THEY SEPARATED THE CATHETER FROM THE STENT, AND THE STENT REMAINED IMPLANTED IN THE PATIENT AS INTENDED. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS TO THE PATIENT AND THE PATIENT¿S CURRENT CONDITION IS REPORTED TO BE ¿STABLE¿.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7165382 ↗
• InjuryApr 24, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA¿ BILIARY PRELOADED STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTICED THAT THE GUIDE CATHETER WAS DETACHED INSIDE THE PATIENT. THE PHYSICIAN USED FORCEPS TO RETRIEVE THE DEVICE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS PROCEDURE, AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE IS REPORTED TO BE "STABLE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6515871 ↗