Epic™ Biliary M00572270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729896890), received between Oct 12, 2018 and Dec 2, 2019 — classified as 2 malfunctions.

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

• MalfunctionDec 2, 2019Difficult or Delayed Positioning; Material Deformation; Material Integrity Problem; Positioning Problem; Difficult or Delayed Positioning; Material Deformation; Material Integrity Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 06, 2019 THAT AN EPIC BILIARY STENT HAS BEEN IMPLANTED TO TREAT A MALIGNANT STENOSIS IN THE LOWER BILE DUCT DURING AN ENDOSCOPIC BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SHEATH STOPPED MOVING AND THE STENT FAILED TO DEPLOY. THE SHEATH WAS PULLED WITH FORCE AND WAS ABLE TO REMOVE THE DEVICE FROM THE BILE DUCT. REPORTEDLY, THE STENT WAS REINSERTED AND WAS RELEASED ALL AT ONCE NEAR THE TARGET LESION. REPORTEDLY, THE STENT REMAINS IMPLANTED BUT A DIFFERENT STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS RECEIVED, AND UPON REVIEW THE SHEATH WAS NOTED TO BE DAMAGED AND THE INNER SHAFT WAS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9396309 ↗
• MalfunctionOct 12, 2018Break; Difficult or Delayed Positioning; Difficult to Remove; Break; Difficult or Delayed Positioning; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING DEPLOYMENT, THE THUMBWHEEL OF THE HANDLE WAS BEING USED; THE STENT WAS ABLE TO BE RELEASED TO AN EXTENT BUT THEN COULD NOT BE FULLY RELEASED. A "SLAP" SOUND WAS HEARD AND THE DISTAL PART OF THE OUTER TUBE GOT SEPARATED. AT THIS TIME THE PHYSICIAN JUDGED THAT THE STENT AND DELIVERY SYSTEM COULD NOT BE RETRIEVED AS IT WAS, AND THE DELIVERY SYSTEM WAS CUT WITH PLIERS WHERE THE HANDLE MEETS THE OUTER AND INNER TUBES. THE OUTER AND INNER TUBE WERE REMOVED TOGETHER WITH THE ENDOSCOPE. IT WAS REPORTED THAT AFTER DELIVERY SYSTEM REMOVAL THE STENT WAS FOUND TO BE PLACED IN THE ORIGINALLY PLANNED LOCATION AND THE STENT REMAINED IMPLANTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7960417 ↗