Epic™ Biliary M00572330Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729896951), received between Feb 14, 2019 and Jun 10, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2024Premature Activation; Failure to Advance; Material Deformation; Premature Activation; Failure to Advance; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A MALIGNANT HILAR STRICTURE DURING AN ENDOSCOPIC ULTRASOUND (EUS) ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH BILATERAL BILIARY STENTING PROCEDURE PERFORMED ON (B)(6), 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED DURING STENT PLACEMENT. DURING THE PROCEDURE, THE FIRST EPIC STENT WAS SUCCESSFULLY PLACED IN THE RIGHT DUCT. HOWEVER, THE SECOND EPIC STENT PLACED IN THE LEFT DUCT WAS NOT ABLE TO CROSS THE STRICTURE AS THE CATHETER WAS KINKED. THE DEVICE WAS REMOVED, AND THE STRICTURE WAS DILATED USING HURRICANE BALLOON. THE SECOND EPIC STENT WAS RE-INTRODUCED AND WAS ABLE TO CROSS THE STRICTURE. THE PHYSICIAN THEN PROCEEDED TO DEPLOY BOTH STENTS, THE EPIC STENT IN THE RIGHT DUCT DEPLOYED SUCCESSFULLY WHILE THE EPIC STENT IN THE LEFT DUCT DID NOT EVEN AFTER COMPLETE ROLLING OF THE THUMB WHEEL. THE SECOND EPIC STENT THEN DEPLOYED IN THE SCOPE WHEN IT WAS BEING REMOVED, AND IT HAD TO BE REMOVED USING FORCEPS. THE PROCEDURE WAS FINALLY COMPLETED WITH A PLASTIC STENT IN THE LEFT DUCT. THERE WERE NO PATIENT COMPLICATIONS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505675 ↗
• MalfunctionApr 10, 2024Failure to Advance; Activation, Positioning or Separation Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Activation, Positioning or Separation Problem; Difficult to Advance; 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 HILAR TO TREAT A HILAR BLOCK WITH MALIGNANCY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THERE WAS A RESISTANCE WHILE ADVANCING THE STENT BUT WAS EVENTUALLY ADVANCED INTO THE PATIENT'S ANATOMY. THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT COULD NOT BE SEEN UNDER FLUOROSCOPY AS THE STENT DID NOT DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT 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 19084479 ↗
• MalfunctionMar 6, 2023Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PROCEDURES INVOLVING ONE EPIC BILIARY STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A 6CM STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH 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, WHEN THE STENT WAS BEING DEPLOYED, THE RADIOPAQUE MARKERS WERE UNABLE TO BE SEEN ON FLUOROSCOPY. THE STENT WAS ALSO NOT FOUND DEPLOYED INSIDE THE PATIENT'S STOMACH AND SURROUNDING DUCTS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A WALLFLEX BILIARY STENT. ON AN UNKNOWN DATE, THE SAME NON-BOSTON SCIENTIFIC SCOPE WAS REPROCESSED AND WAS USED IN A DIFFERENT PROCEDURE. DURING THE PROCEDURE, A PLASTIC STENT WAS ADVANCED THROUGH THE SCOPE BUT BECAME STUCK. WHEN THE SCOPE WAS REMOVED AND CHECKED, THE EPIC BILIARY STENT FROM THE PREVIOUS PROCEDURE WAS FOUND DEPLOYED AND WAS PULLED OUT OF THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16487383 ↗
• MalfunctionMar 3, 2023Premature Activation; Poor Visibility; Premature Activation; Poor Visibility

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO PROCEDURES INVOLVING ONE EPIC BILIARY STENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A 6CM STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH 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, WHEN THE STENT WAS BEING DEPLOYED, THE RADIOPAQUE MARKERS WERE UNABLE TO BE SEEN ON FLUOROSCOPY. THE STENT WAS ALSO NOT FOUND DEPLOYED INSIDE THE PATIENT'S STOMACH AND SURROUNDING DUCTS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A WALLFLEX BILIARY STENT. ON AN UNKNOWN DATE, THE SAME NON-BOSTON SCIENTIFIC SCOPE WAS REPROCESSED AND WAS USED IN A DIFFERENT PROCEDURE. DURING THE PROCEDURE, A PLASTIC STENT WAS ADVANCED THROUGH THE SCOPE BUT BECAME STUCK. WHEN THE SCOPE WAS REMOVED AND CHECKED, THE EPIC BILIARY STENT FROM THE PREVIOUS PROCEDURE WAS FOUND DEPLOYED AND WAS PULLED OUT OF THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481988 ↗
• MalfunctionFeb 10, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE MID-COMMON BILE DUCT TO TREAT AN APPROXIMATELY 3-5 CM HILAR CHOLANGIOCARCINOMA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH A BILIARY SELF-EXPANDING METAL STENT (SEMS) IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE EPIC BILIARY STENT WAS UNABLE TO DEPLOY EVEN AFTER COMPLETELY PULLING BACK THE HANDLE AND CLICKING THE THUMB WHEEL. THE EPIC BILIARY STENT WAS REMOVED PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 16358615 ↗
• MalfunctionDec 24, 2020Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE HANDLE MOVED BUT STENT RELEASE COULD NOT BE STARTED AT ALL. THE PHYSICIAN SHOOK AND JIGGLED THE DELIVERY SYSTEM BUT THE STENT WOULD NOT DEPLOY. REPORTEDLY, THE STENT WAS FULLY RETRACTED WHEN IT WAS REMOVED FROM THE PATIENT AND A DIFFERENT STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD EFFORTS. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE EPIC BILIARY ENDOSCOPIC STENT WAS PARTIALLY DEPLOYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11072121 ↗
• InjuryNov 24, 2020Device-Device Incompatibility; Material Deformation; Positioning Problem; Activation Failure; Device-Device Incompatibility; Material Deformation; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 THAT AN EPIC BILIARY STENT WAS IMPLANTED TO TREAT A 7CM MALIGNANT STRICTURE IN THE RIGHT HEPATIC DUCT EXTENDING TO THE COMMON BILE DUCT UP TO THE PAPILLA DURING A BILATERAL STENTING OF LEFT AND RIGHT HEPATIC DUCTS PROCEDURE PERFORMED ON (B)(6), 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, IT WAS NOTED THROUGH FLUOROSCOPY THAT THE STENT FAILED TO EXPAND. UPON REMOVAL OF THE DELIVERY SYSTEM, IT WAS NOTED THAT THE STENT WAS DEPLOYED IN AN INCORRECT POSITION. REPORTEDLY, THERE WAS A LOT OF RESISTANCE WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE. THE GUIDEWIRE WAS ENTANGLED INTO THE MESH OF THE STENT WHICH CAUSED THE STENT TO COMPLETELY CRUMBLE. THE WIRE WAS UNABLE TO BE REMOVED. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE AND STABLE. REPORTEDLY, A SURGERY WILL BE PERFORMED TO REMOVE THE STENT ALONG WITH THE GUIDEWIRE; HOWEVER, DETAILS REGARDING THE SURGERY WERE UNAVAILABLE BECAUSE THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY. A PHOTO PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 10895351 ↗
• MalfunctionSep 22, 2020Premature Activation; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Integrity Problem; Premature Activation; Difficult to Remove; Failure to Advance; Deformation Due to Compressive Stress; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 01, 2020 THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE IN THE COMMON BILE DUCT DUE TO CHOLANGIOCARCINOMA DURING A BILIARY STENTING PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DELIVERY SYSTEM HAD DIFFICULTY CROSSING THE LESION INITIALLY. ONCE THE PHYSICIAN WAS ABLE TO CROSS THE STRICTURE THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT FAILED TO DEPLOY EVEN AFTER ROTATING/TURNING THE THUMBWHEEL FOR 20 CLICKS. THE DEVICE WAS THEN ATTEMPTED TO BE REMOVED BUT THE STENT WAS NOT COMING OUT SO THE SCOPE WAS PULLED BACK. UPON REMOVAL, THE STENT PREMATURELY DEPLOYED IN THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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. A PHOTO PROVIDED BY THE COMPLAINANT OUTSIDE THE PATIENT SHOWS THE SHEATH WAS TWISTED AND BUCKLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567765 ↗
• MalfunctionMar 26, 2020Difficult or Delayed Positioning; Entrapment of Device; Material Deformation; Difficult or Delayed Positioning; Entrapment of Device; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EPIC BILIARY STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. IT WAS REPORTED THAT THE ANATOMY WAS DILATED PRIOR TO THE STENT PLACEMENT PROCEDURE AND THE PATIENT HAD A SLIGHTLY TORTUOUS ANATOMY. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN LINED UP THE RO MARKER TO DEPLOY THE STENT IN THE BILE DUCT; HOWEVER, THE STENT FULLY DEPLOYED IN THE SCOPE. THE STENT WAS REMOVED FROM THE SCOPE WHEN ANOTHER STENT WAS PASSED DOWN THE WORKING CHANNEL OF THE SCOPE. THE PROCEDURE WAS COMPLETED WITH A WALLFLEX 10X80 STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT DEFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9885566 ↗
• MalfunctionDec 12, 2019Difficult or Delayed Positioning; Positioning Problem; Difficult or Delayed Positioning; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT AN EPIC BILIARY ENDOSCOPIC STENT HAS BEEN IMPLANTED TO TREAT A SEVERE MALIGNANT STENOSIS IN THE DISTAL BILE DUCT DURING A BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE COMPLAINANT STATED "THE STENT WAS PLACED UNDER SEVERE CONDITION WHERE DISTANCE FROM THE PAPILLA COULD NOT BE TAKEN". ACCORDING TO THE COMPLAINANT, DURING STENT DEPLOYMENT, THE THUMBWHEEL WAS ROTATED BUT THE STENT WAS UNABLE TO RELEASE EASILY. REPORTEDLY, WHEN THE THUMB WHEEL DELIVERY WAS CLOSE TO NEARLY HALF COMPLETED, RELEASE SUDDENLY STARTED AND THE STENT JUMPED ABOUT 1.5 MM AND MOVED INTO THE BILE DUCT. THE STENT REMAINS IMPLANTED AND A DIFFERENT STENT WAS IMPLANTED SLIGHTLY OUT OF THE PAPILLA TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9459928 ↗
• MalfunctionFeb 14, 2019Entrapment of Device; Premature Activation; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Material Deformation; Entrapment of Device; Premature Activation; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 21, 2019 THAT AN EPIC BILIARY STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE COMMON BILE DUCT DUE TO CHOLANGIOCARCINOMA (CCA) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DELIVERY CATHETER KINKED BETWEEN THE ELEVATOR AND PAPILLA, WHICH CAUSED DIFFICULTY IN PLACING THE STENT. REPORTEDLY, THE STENT WAS PARTIALLY DEPLOYED AND COULD NOT FINISH THE DEPLOYMENT. THE STENT WAS PULLED BACK THROUGH THE SCOPE BUT, THE STENT GOT CAUGHT IN THE SCOPE, AND WAS PREMATURELY DEPLOYED INSIDE THE SCOPE. THE STENT AND THE SCOPE WERE REMOVED AND A WALLFLEX BILIARY UNCOVERED STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341390 ↗