Epic™ Biliary M00572250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729896876), received between Jun 29, 2020 and May 27, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjuryMay 27, 2022Premature Activation; Premature Activation

  THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-02782 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT TWO EPIC BILIARY STENTS WERE TO BE USED TO TREAT A HILAR STRICTURE DURING AN INTERVENTIONAL RADIOLOGY (IR) AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FIRST EPIC BILIARY STENT WAS DEPLOYED SUCCESSFULLY (THE SUBJECT OF MFR. REPORT # 3005099803-2022-02782). A SECOND EPIC BILIARY STENT (THE SUBJECT OF THIS REPORT) WAS ATTEMPTED TO BE USED; HOWEVER, THE STENT PREMATURELY DEPLOYED AND DISRUPTED THE FIRST STENT. BOTH STENTS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED VIA AN ALTERNATIVE METHOD OR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14524901 ↗
• InjuryMay 27, 2022Positioning Problem; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2022-02782 AND 33005099803-2022-02783 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT TWO EPIC BILIARY STENTS WERE TO BE USED TO TREAT A HILAR STRICTURE DURING AN INTERVENTIONAL RADIOLOGY (IR) AND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED WITH STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FIRST EPIC BILIARY STENT WAS DEPLOYED SUCCESSFULLY (THE SUBJECT OF THIS REPORT). A SECOND EPIC BILIARY STENT (THE SUBJECT OF MFR. REPORT # 33005099803-2022-02783) WAS ATTEMPTED TO BE USED; HOWEVER, THE STENT PREMATURELY DEPLOYED AND DISRUPTED THE FIRST STENT. BOTH STENTS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED VIA AN ALTERNATIVE METHOD OR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523121 ↗
• MalfunctionJul 13, 2021Entrapment of Device; Difficult to Remove; Failure to Advance; Activation, Positioning or Separation Problem; Entrapment of Device; Difficult to Remove; Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 22, 2021 THAT AN EPIC BILIARY ENDOSCOPIC STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE MIDDLE OF THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, AN EPIC BILIARY STENT WAS SUCCESSFULLY DEPLOYED BUT SINCE THE STRICTURE EXTENDED PAST THE STENT, THE PHYSICIAN DECIDED TO PLACE ANOTHER EPIC STENT TO BRIDGE THE STRICTURE. THE SECOND STENT WAS ATTEMPTED TO BE PLACED THROUGH THE INITIAL STENT, BUT THERE WAS DIFFICULTY ADVANCING IT THROUGH THE AMPULLA DUE TO INFLAMMATION. THE AMPULLA WAS DILATED WITH A CRE BALLOON. THE STENT WAS ABLE TO BE ADVANCED INTO THE CORRECT POSITION AND DEPLOYMENT WAS INITIATED; HOWEVER, THE THUMBWHEEL STOPPED WORKING AND THE STENT WAS ONLY ABLE TO BE DEPLOYED 1 CM. THE PHYSICIAN ATTEMPTED TO USE THE GRASP AND PULL METHOD BUT WAS ONLY ABLE TO DEPLOY THE STENT 1.5 CM. THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE AND THE GUIDEWIRE GOT STUCK IN THE EPIC STENT DURING REMOVAL. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND A WALLFLEX BILIARY STENT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159425 ↗
• MalfunctionJun 29, 2020Activation, Positioning or Separation Problem; Difficult to Advance; Activation, Positioning or Separation Problem; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 05, 2020 THAT AN EPIC BILIARY STENT WAS USED TO BE IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN ADVANCING THE STENT INTO THE SCOPE, IT WAS NOTICED THAT THE STENT WAS UNABLE TO ADVANCE ALONG WITH THE GUIDEWIRE. THE STENT WAS REMOVED AND UPON REMOVAL, IT WAS NOTED THAT THE GUIDEWIRE JACKET WAS FRAYED AND THE STENT WAS NOTED TO BE PARTIALLY DEPLOYED. PLASTIC STENTS WERE IMPLANTED TO COMPLETE THE PROCEDURE AND THE PATIENT WILL BE BROUGHT BACK FOR ANOTHER EPIC STENT PLACEMENT PROCEDURE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10207402 ↗