Epic™ Biliary M00572310Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729896937), received between Nov 30, 2022 and Nov 30, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2022Premature Activation; Difficult to Remove; Material Deformation; Premature Activation; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 8, 2022, THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED TO TREAT A 6CM STENOSIS IN THE DISTAL BILE DUCT DUE TO PANCREATIC CANCER DURING AN ENDOSCOPIC BILIARY STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE EPIC BILIARY STENT DID NOT DEPLOY DESPITE THE PHYSICIAN PULLING THE OUTER SHEATH BACK AND FORTH. THE PHYSICIAN THEN DECIDED TO REMOVE THE DEVICE; HOWEVER, DURING REMOVAL, THE DELIVERY SYSTEM BECAME STUCK IN AN UPRIGHT POSITION AT THE TIP OF THE SCOPE, AND THE EPIC BILIARY STENT DEPLOYED PREMATURELY INSIDE THE SCOPE. THE EPIC BILIARY STENT WAS REMOVED TOGETHER WITH THE SCOPE, AND THE PROXIMAL END OF THE STENT WAS NOTED TO BE KINKED. A PLASTIC STENT WAS IMPLANTED 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 15885202 ↗