Epic™ Biliary M00572240Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729896869), received between Mar 26, 2018 and Mar 2, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 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 TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING PREPARATION, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED. ANOTHER EPIC BILIARY ENDOSCOPIC STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469222 ↗
• InjuryJun 16, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE REVOLUTION GUIDEWIRE AND TWO EPIC BILIARY STENTS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH BILATERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE EPIC BILIARY STENTS WERE IMPLANTED IN THE BILE DUCT TO TREAT A MALIGNANT STRICTURE DUE TO CHOLANGIOCARCINOMA. THE PATIENT'S ANATOMY WAS REPORTED TO BE TIGHT. DURING THE PROCEDURE, TWO 6X100MM EPIC BILIARY STENTS WERE SUCCESSFULLY IMPLANTED BILATERALLY AT THE HEPATIC DUCT BIFURCATION. THE PHYSICIAN CHOSE TO PLACE ONE OF THE 6X100MM EPIC BILIARY STENTS MORE PROXIMAL WITHIN THE DUCT. A 6X60MM EPIC BILIARY STENT WAS THEN PLACED INSIDE THE MORE PROXIMAL 6X100MM EPIC BILIARY STENT TO BRIDGE THE AMPULLA AND HAVE THE STENT COME OUT TRANSPAPILLARY. UPON REMOVAL OF THE DELIVERY SYSTEM OF THE 6X60MM EPIC BILIARY STENT, THE DISTAL TIP OF THE CATHETER DETACHED INSIDE THE PATIENT. UNDER ENDOSCOPIC VIEW IT WAS NOTED THAT THE ORANGE FLOATING BUMPER OF THE INNER SHAFT WAS DISLODGED AND GOT STUCK IN THE DISTAL COMMON BILE DUCT. WHEN THE PHYSICIAN ATTEMPTED TO REMOV

  Patient problems: Foreign Body In Patient

  MAUDE report 14718992 ↗
• MalfunctionDec 14, 2020Difficult to Remove; Difficult to Advance; Positioning Problem; Difficult to Remove; Difficult to Advance; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED TO TREAT A 3CM MALIGNANT RECURRENT PANCREATIC HEAD MASS IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS ALTERED DUE TO WHIPPLE SURGERY AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE EPIC BILIARY STENT WAS UNABLE TO ADVANCE INTO THE PATIENT'S ANATOMY DUE TO THE GUIDEWIRE MOVING. THE EPIC BILIARY STENT WAS REMOVED AND THE PHYSICIAN REQUESTED A WALLFLEX 8MM X 60MM UNCOVERED BILIARY STENT AND ATTEMPTED TO ADVANCE INTO THE DUCT; HOWEVER, THE STENT WAS UNABLE TO ADVANCE ALL THE WAY INTO THE DUCT. CONSEQUENTLY, THE STENT WAS REMOVED ALONG WITH THE GUIDEWIRE. A NEW HYDRAJAG GUIDEWIRE WAS PLACED AND THE EPIC BILIARY ENDOSCOPIC STENT WAS RE-INSERTED. THIS TIME THE STENT WAS ABLE TO ADVANCE INTO THE DUCT; HOWEVER, THE STENT WAS DEPLOYED SLIGTHLY PROXIMAL TO THE TARGET REGION. REPORTEDLY, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE AND AFTER SEVERAL ATTEMPTS, THE WHOLE SCOPE AND DELIVERY CA

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11005948 ↗
• InjuryMar 26, 2018Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN EPIC BILIARY STENT WAS IMPLANTED TO TREAT A MALIGNANT BILIARY STENOSIS DURING A SIDE-BY-SIDE (SBS) STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A GUIDEWIRE WAS PLACED IN THE RIGHT HEPATIC DUCT AND A SECOND NON-BSC GUIDEWIRE WAS PASSED TOWARDS THE LEFT HEPATIC DUCT. HOWEVER, ONLY 2-3 CM OF THE GUIDEWIRE WAS ABLE TO ADVANCE 2-3 CM FROM THE HEPATIC PORTAL. THE STENT ADVANCED INTO THE RIGHT DUCT WAS DEPLOYED WITHOUT ISSUE. THERE WAS DIFFICULTY ADVANCING THE EPIC BILIARY STENT INTO THE LEFT HEPATIC DUCT. THE STENT WAS REMOVED AND THEN PLACED AGAIN WITHIN THE LEFT DUCT. THE STENT WAS ABLE TO BE SUCCESSFULLY DEPLOYED BUT WHEN THE GUIDEWIRE WAS ATTEMPTED TO BE REMOVED, RESISTANCE WAS ENCOUNTERED. ADDITIONAL FORCE WAS EXERTED, THE GUIDEWIRE WAS FORCIBLY PULLED AND BECAME ENTANGLED WITH THE STENT. SUBSEQUENTLY, AN ANGIOGRAPHIC CATHETER WAS INSERTED TO UNRAVEL THE ENTANGLED PART OF THE GUIDEWIRE BUT IT WAS NOT UNRAVELED AND WAS NOT REMOVED. THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE AND STENT BY USING GRASPING F

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7370987 ↗