Epic™ Biliary M00572340Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729896968), received between Feb 2, 2018 and Nov 5, 2025 — classified as 4 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (17 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS REPORT PERTAINS TO ONE OF TWO EPIC BILIARY STENTS USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2025-05832 AND 3005099803-2025-05833 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO (2) EPIC BILIARY STENTS WERE TO BE IMPLANTED IN THE RIGHT AND LEFT HEPATIC DUCTS TO TREAT A MALIGNANT CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH BILATERAL STENTING PROCEDURE PERFORMED ON OCTOBER 14, 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING A BILATERAL STENTING PROCEDURE, THE FIRST EPIC STENT (SUBJECT OF THIS REPORT) DID NOT OPEN UP, AND THE SECOND EPIC STENT (SUBJECT OF MANUFACTURER REPORT# 3005099803-2025-05833) DID NOT OPEN UP AS WELL. THE STENTS WERE REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477905 ↗
• MalfunctionNov 5, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS REPORT PERTAINS TO ONE OF TWO EPIC BILIARY STENTS USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2025-05832 AND 3005099803-2025-05833 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO (2) EPIC BILIARY STENTS WERE TO BE IMPLANTED IN THE RIGHT AND LEFT HEPATIC DUCTS TO TREAT A MALIGNANT CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH BILATERAL STENTING PROCEDURE PERFORMED ON OCTOBER 14, 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING A BILATERAL STENTING PROCEDURE, THE FIRST EPIC STENT (SUBJECT OF MANUFACTURER REPORT# 3005099803-2025-05832) DID NOT OPEN UP, AND THE SECOND EPIC STENT (SUBJECT OF THIS REPORT) DID NOT OPEN UP AS WELL. THE STENTS WERE REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477891 ↗
• MalfunctionJun 3, 2025Break; Positioning Failure; Detachment of Device or Device Component; Material Deformation; Break; Positioning Failure; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS USED TO TREAT AN APPROXIMATELY 3CM MALIGNANT HILAR STRICTURE DURING A BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. A PLASTIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE WERE PROVIDED, AND IT WAS OBSERVED THAT THE OUTER BLUE SHEATH WAS BROKEN, AND THE INNER SHEATH WAS KINKED. THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHEATH WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137569 ↗
• MalfunctionJan 8, 2025Break; Positioning Failure; Detachment of Device or Device Component; Break; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS USED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DURING A BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE FIRST STENT WAS SUCCESSFULLY PLACED IN THE LEFT HILAR DUCT; HOWEVER, THE SECOND STENT COULD NOT BE DEPLOYED AND WHILE PULLING OUT THE STENT, THE HANDLE WAS BROKEN. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE INNER SHEATH WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105767 ↗
• MalfunctionOct 11, 2024Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED TO TREAT A BILIARY OBSTRUCTION IN THE BILIARY DUCT CAUSED BY A MALIGNANT STRICTURE ABOVE THE HILAR REGION DURING A BILIARY SELF- EXPANDING METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DEPLOYMENT THUMBWHEEL WAS ROTATED TO DEPLOY THE STENT; HOWEVER, THE SHEATH REMAINED IN POSITION AND THE STENT DID NOT DEPLOY. WHILE REMOVING THE STENT CATHETER, THE SHEATH MOVED, AND THE STENT DEPLOYED PREMATURELY INSIDE THE SCOPE. THE STENT GOT STUCK AND WAS REMOVED TOGETHER WITH THE SCOPE. ANOTHER EPIC BILIARY STENT AND SCOPE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20430282 ↗
• InjurySep 19, 2024Use of Device Problem; Difficult to Advance; Positioning Problem; Use of Device Problem; Difficult to Advance; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE LEFT HEPATIC BILE DUCT TO TREAT A BILIARY STRICTURE DUE TO CHOLANGIOCARCINOMA DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE YELLOW LUER LOCK FLUSHING ATTACHMENT WAS NOT REMOVED FROM THE BACK OF THE EPIC DEVICE, AND THE GUIDEWIRE DID NOT COME OUT OF THE EPIC STENT. THE STENT WAS ABLE TO BE FULLY DEPLOYED; HOWEVER, THE STENT WAS DEPLOYED MORE DISTAL TO THE RIGHT HEPATIC DUCT. THE PHYSICIAN USED AN ARGON PLASMA COAGULATION APC TO CUT A PORTION OF THE STENT THAT WAS PLACED IN THE DUODENUM, AND A DIFFERENT STENT WAS PLACED STENT-IN-STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE CUSTOMER DID NOT REMOVE THE YELLOW LUER LOCK FLUSHING ATTACHMENT FROM THE BACK OF THE EPIC BILIARY STENT. HOWEVER, THE EPIC BILIARY ENDOSCOPIC INSTRUCTIONS FOR USE STATE, "REMOVE THE FLUSHING LUER" THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE INSTRUCTIONS FOR USE (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262589 ↗
• MalfunctionJul 1, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE HILAR TO TREAT A 2CM TO 4CM MALIGNANT HILAR STRICTURE DURING A METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, DUE TO RESISTANCE THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND A PLASTIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650727 ↗
• InjuryJan 19, 2024Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT TO TREAT AN APPROXIMATELY 4CM MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ADVANCED AND DEPLOYED; HOWEVER, THE STENT WAS UNABLE TO FULLY EXPAND. A HURRICANE BALLON WAS USED TO FULLY EXPAND THE STENT BUT IT WAS UNABLE TO PASS THROUGH THE STENT. SUBSEQUENTLY, THE PATIENT WAS REFERRED TO INTERVENTIONAL RADIOLOGY FOR A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) PROCEDURE. THE STENT REMAINED IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544117 ↗
• MalfunctionDec 22, 2023Positioning Failure; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE HILAR REGION OF THE COMMON BILE DUCT TO TREAT A 5CM MALIGNANT STRICTURE SECONDARY TO CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED DESPITE REPEATEDLY USING THE THUMBWHEEL AND PULL-GRIP DEPLOYMENT METHODS. THE STENT WAS COVERED BY THE OUTER SHEATH WHEN REMOVED FROM THE PATIENT, BUT IT AUTOMATICALLY OPENED. THE PROCEDURE WAS COMPLETED WITH A PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING WHICH REVEALED THE STENT WAS PARTIALLY DEPLOYED. PLEASE SEE BLOCK H10 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18383972 ↗
• MalfunctionDec 21, 2023Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS USED TO TREAT A MALIGNANT STRICTURE IN THE RIGHT AND LEFT HILAR DUCTS DURING A BILATERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE FIRST EPIC BILIARY STENT WAS DEPLOYED; HOWEVER, THE SECOND STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. A PLASTIC STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS RETURNED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379480 ↗
• MalfunctionOct 30, 2023Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A 4CM CHOLANGIOCARCINOMA DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY COMPLETELY EVEN AFTER MULTIPLE ATTEMPTS. THE STENT WAS PARTIALLY COVERED BY THE OUTER SHEATH ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. A NON-BOSTON SCIENTIFIC DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18032132 ↗
• MalfunctionSep 8, 2023Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS USED TO TREAT A MALIGNANT HILAR STRICTURE DURING A BILATERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ONLY ONE EPIC BILIARY STENT BEING PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE EPIC BILIARY STENT WAS PARTIALLY DEPLOYED. ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 08, 2023 WHILE REMOVING THE DELIVERY SYSTEM, THE STENT WAS PARTIALLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710585 ↗
• MalfunctionJul 17, 2023Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 29, 2023, THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED TO TREAT GASTRIC OUTLET OBSTRUCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH FLUOROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT FULLY DEPLOYED INSIDE THE SCOPE. NO ADDITIONAL STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE STENT WAS INTENDED TO BE PLACED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO). HOWEVER, PER THE EPIC BILIARY ENDOSCOPIC STENT SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INTENDED TO TREAT PATIENTS WITH BILIARY STRICTURES CREATED BY MALIGNANT NEOPLASMS AND IS TO BE DELIVERED ENDOSCOPICALLY. THE DEVICE IS NOT INDICATED TO BE PLACED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17338941 ↗
• MalfunctionJun 8, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 23, 2023 THAT AN EPIC BILIARY STENT WAS USED TO TREAT A 6CM MALIGNANT STRICTURE IN THE BILE DUCT DURING A BILATERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. THE STENT WAS PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EPIC BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17094123 ↗
• InjuryJun 6, 2023Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 18, 2023 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE LEFT HEPATIC DUCT TO TREAT A 3CM MALIGNANT STENOSIS DUE TO HILAR CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE CATHETER BROKE AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS NOT COMPLETED. ON (B)(6) 2023, AN ENDOSCOPIC ULTRASOUND- HEPATICOGASTROSTOMY WAS SUCCESSFULLY PERFORMED. THE PATIENT EXPERIENCED ABNORMAL LIVER FUNCTION TESTS AND BLOOD COUNTS AND WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT COMPLICATIONS ARE RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE STABLE. A PHOTO OF THE DEVICE PROVIDED BY THE COMPLAINANT SHOWS THAT THE STENT WAS FULLY COVERED BY THE OUTER SHEATH, THE OUTER SHEATH WAS DETACHED, AND THE INNER SHEATH WAS KINKED.

  Patient problems: Insufficient Information

  MAUDE report 17071308 ↗
• MalfunctionMay 31, 2023Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 10, 2023, THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE LEFT AND RIGHT HEPATIC DUCTS TO TREAT A MALIGNANT HILAR STRICTURE DURING A HILAR STRICTURE METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE GUIDEWIRE WOULD NOT MOVE FORWARD AND PASS THROUGH THE DEVICE DELIVERY SYSTEM. THE EPIC BILIARY STENT WAS REMOVED, AND THE GUIDEWIRE WAS LOADED OUTSIDE THE PATIENT, BUT IT WOULD STILL NOT MOVE. THE PROCEDURE WAS NOT COMPLETED BECAUSE THE SAME DEVICE WAS NOT AVAILABLE AT THE HOSPITAL. ON (B)(6) 2023, THE SAME PROCEDURE WAS PERFORMED ON THE PATIENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE USED WAS A 0.25 GUIDEWIRE. PER THE DIRECTIONS FOR USE (DFU), THE REQUIRED GUIDEWIRE TO USE IS A 0.035 IN (0.89 MM) STIFF-BODIED GUIDEWIRE. THE USER DID NOT USE THE REQUIRED GUIDEWIRE FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17033107 ↗
• MalfunctionApr 10, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN EPIC BILIARY STENT WAS USED TO TREAT A 5MM CHOLANGIOCARCINOMA DURING A BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY EVEN AFTER COMPLETE ROTATION OF THE THUMBWHEEL. THE TECHNICIAN ALSO TRIED THE PULL DEPLOYMENT METHOD BUT THE STENT WAS STILL UNABLE TO DEPLOY. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708232 ↗
• MalfunctionMar 27, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 14, 2023, THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT STRICTURE DUE TO CANCER DURING A BILIARY METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TIGHT BUT NOT TORTUOUS AND WAS DILATED WITH HURRICANE DILATATION BALLOON PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED THE EPIC BILIARY STENT USING THE THUMBWHEEL METHOD; HOWEVER, THE STENT WAS NOT DEPLOYED. DURING REMOVAL, THE STENT PARTIALLY OPENED INSIDE THE SCOPE, AND IT WAS PARTIALLY RELEASED ONTO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16621320 ↗
• MalfunctionFeb 28, 2023Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN EPIC BILIARY STENT WAS USED IN THE BILIARY TREE TO TREAT A CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE FIRST STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE EPIC BILIARY STENT WAS UNABLE TO FULLY DEPLOY EVEN AFTER ALL CLICKS ON THE THUMBWHEEL WERE COMPLETED. THE EPIC BILIARY STENT WAS PARTIALLY COVERED BY THE DEPLOYMENT SUTURE ON THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED AS THE DEPLOYED STENT CAUSED THE PARALLEL VESSEL TO CONSTRICT AND WOULD NOT BE POSSIBLE TO DEPLOY ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452564 ↗
• MalfunctionFeb 22, 2023Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 31, 2023, THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE BILIARY TREE TO TREAT A HILAR CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENTING PROCEDURES PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURES, THE EPIC BILIARY ENDOSCOPIC STENT DID NOT DEPLOY AFTER CLICKING THE THUMB WHEEL MULTIPLE TIMES AND EVEN USING THE MANUAL PULL GRIP METHOD DUE TO THE CONSTRICTION OF THE PARALLEL BLOOD VESSEL DUE TO THE FIRST EPIC BILIARY ENDOSCOPIC STENT THAT WAS SUCCESSFULLY DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT, FULLY COVERED BY THE OUTER SHEATH, AND THE PROCEDURE WAS CANCELLED. REPORTEDLY, NO PROCEDURE WAS SCHEDULED FOR ANOTHER STENT PLACEMENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WAS PROVIDED BY THE COMPLAINANT AND SHOWED THAT THE SHEATH WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16422651 ↗
• MalfunctionOct 12, 2022Break; Use of Device Problem; Failure to Advance; Material Deformation; Break; Use of Device Problem; Failure to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A 6CM BENIGN STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, WHILE ADVANCING THE EPIC BILIARY DELIVERY SYSTEM THROUGH THE STRICTURE, THE OUTER SHEATH KINKED AND BROKE. CONSEQUENTLY, THE EPIC BILIARY DELIVERY SYSTEM WAS UNABLE TO ADVANCE TO THE TARGET ANATOMY. THE EPIC BILIARY ENDOSCOPIC STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. IT WAS REPORTED THAT THE EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED TO TREAT A BENIGN STRICTURE. HOWEVER, PER EPIC BILIARY ENDOSCOPIC STENT SYSTEM DIRECTIONS FOR USE (DFU), THE DEVICE IS INDICATED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE. THE EPIC BILIARY STENT IS CONTRAINDICATED FOR PLACEMENT IN BILIARY STRICTURES CAUSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586848 ↗
• MalfunctionSep 8, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT AN 8CM MALIGNANT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH SELF-EXPANDING METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE EPIC BILIARY STENT COULD NOT BE DEPLOYED MORE THAN 10% OF ITS LENGTH. THE THUMBWHEEL AND THE PULL GRIP WERE BOTH UTILIZED TO DEPLOY THE EPIC BILIARY STENT BUT WAS UNSUCCESSFUL. THE EPIC BILIARY STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM AND A DIFFERENT DEVICE WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381561 ↗
• InjuryJul 21, 2022Break; Difficult to Remove; Activation, Positioning or Separation Problem; Break; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS IMPLANTED TO TREAT A MALIGNANT STENOSIS IN THE COMMON HEPATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH METALLIC AUTO EXPANSIBLE STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE EPIC BILIARY STENT WAS PARTIALLY DEPLOYED. IT WAS NOT THAT THE STENT MAXED OUT ON THE THUMB WHEEL AND WAS UNABLE BE DELIVERED ANYMORE. THE PHYSICIAN ATTEMPTED TO REMOVE THE PARTIALLY DEPLOYED EPIC BILIARY STENT WITH FORCEPS AND BASKET. DURING REMOVAL, THE EPIC BILIARY STENT BROKE INTO TWO PIECES, AND HALF OF THE STENT REMAINED INSIDE THE PATIENT. CHOLANGIOGRAPHY WAS PERFORMED AND IT WAS DETERMINED THAT THE STENT THAT REMAINED INSIDE THE PATIENT WAS THE SAME SIZE AS THE STENOSIS. THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IMPLANTED AS THE STENT DID NOT PRESENT A RISK TO THE PATIENT. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15076359 ↗
• MalfunctionMay 27, 2022Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT TWO EPIC BILIARY ENDOSCOPIC STENTS WERE TO BE USED TO TREAT A MALIGNANT HILAR BILIARY OBSTRUCTION DURING A BILATERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHILE TRYING TO DEPLOY THE STENTS SIDE BY SIDE, ONE EPIC BILIARY STENT WAS DEPLOYED SUCCESSFULLY HOWEVER, THE SECOND EPIC BILIARY STENT DID NOT DEPLOY. THE PHYSICIAN TRIED TO PULL THE CATHETER BUT STILL THE SECOND EPIC BILIARY STENT WAS UNABLE TO RELEASE FROM THE DELIVERY SYSTEM. THE SECOND EPIC BILIARY STENT WAS REMOVED FROM THE PATIENT UNDEPLOYED BUT WHEN THE STENT WAS COMING OUT OF THE SCOPE IT WAS PARTIALLY DEPLOYED. A PLASTIC STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523010 ↗
• MalfunctionApr 1, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 11, 2022 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A HILAR CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) WAS PERFORMED THE NEXT DAY TO TREAT THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978379 ↗