Advanix™ Pancreatic Stent M00536560Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729857501), received between Oct 5, 2017 and Mar 4, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT TO TREAT CHRONIC PANCREATITIS DURING A PANCREATIC DUCT STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. UPON INSPECTION, THE STENT WAS FOUND TO BE FLATTENED. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518554 ↗
• MalfunctionMay 18, 2023Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX PANCREATIC STENT WAS ATTEMPTED TO BE PLACED DURING AN ENDOSCOPIC PANCREATIC STENT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE ADVANIX PANCREATIC STENT WAS LOADED INTO THE DELIVERY SYSTEM, THE LUMEN OF THE STENT FELT FLATTENED, HARD AND DIFFICULT TO INSERT. THE ADVANIX PANCREATIC STENT WAS ABLE TO ADVANCE INTO THE TARGET SITE FOR DEPLOYMENT, HOWEVER, DUE TO STRONG RESISTANCE, THE STENT COULD NOT BE RELEASED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS OR INJURY REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16957334 ↗
• MalfunctionFeb 3, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS FOUND TO BE KINKED AND TWISTED LEADING THE STENT TO BE UNABLE TO RELEASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT HAPPENED DURING THE PROCEDURE AND IT WAS NOTICED THAT THE STENT WAS TWISTED WHEN THE DEVICE WAS UNPACKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274363 ↗
• MalfunctionSep 20, 2018Difficult or Delayed Positioning; Material Deformation; Difficult or Delayed Positioning; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE PANCREAS PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE ADVANIX PANCREATIC STENT WAS ATTEMPTED TO DEPLOY IN THE PANCREAS, SEVERE RESISTANCE WAS ENCOUNTERED WHEN THE STENT WAS RELEASED. REPORTEDLY, WHEN THE PAPILLA SIDE OF THE DEPLOYED PANCREATIC DUCT STENT WAS PULLED, THE STENT KINKED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7894010 ↗
• MalfunctionJul 2, 2018Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ PANCREATIC STENT WAS TO BE USED FOR PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED IN THE PANCREATIC DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, WHEN FLUSHING WAS PERFORMED BY SALINE, THE PHYSICIAN FOUND A SMALL BEND IN THE FLAP PART. THE PROCEDURE WAS COMPLETE WITH ANOTHER ADVANIX¿ PANCREATIC STENT. 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 "GOOD".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656940 ↗
• MalfunctionDec 27, 2017Kinked; Kinked

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2017-03865, 3005099803-2017-03869, 3005099803-2017-03866 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2017. AS THE PHYSICIAN INTRODUCED A 7FRX 11CM ADVANIX PANCREATIC STENT INTO THE PATIENT¿S PANCREATIC DUCT, HE EXPERIENCED SOME RESISTANCE. THE STENT WAS ADVANCED INTO POSITION AND WHEN THE TECHNICIAN ATTEMPTED TO DEPLOY THE STENT THE DELIVERY SYSTEM AND ADVANIX PANCREATIC STENT BOTH BUCKLED/CRUNCHED UP WHICH WOULD NOT ALLOW THE STENT TO RELEASE FROM THE CATHETER. THE DEVICE WAS REMOVED FROM THE SCOPE. THEY THEN ATTEMPTED TO PLACE A 5FRX9CM ADVANIX PANCREATIC STENT OVER A GUIDEWIRE AND PUSH IT INTO POSITION WITH A HYDRATOME. DURING THE ADVANCING OF THE 5FRX9CM ADVANIX PANCREATIC STENT, IT TOO BUCKLED AND HAD TO BE REMOVED. FINALLY, A NAVIFLEX PANCREATIC DELIVERY SYSTEM WAS LOADED WITH THE 7FRX9CM ADVANIX PANCREATIC STENT AND ATTEMPTED TO BE PUSHED INTO POSITION. THE STENT WAS IN POSITION AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7148578 ↗
• MalfunctionOct 5, 2017Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT USED DURING A PANCREATIC STENT REPLACEMENT PROCEDURE PERFORMED IN THE PANCREATIC DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, WHEN THE ADVANIX PANCREATIC STENT WAS ADVANCED TO THE TARGET AREA, THE DEVICE BECAME STUCK AND THE INNER CATHETER WAS UNABLE TO BE PULLED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; PANCREATIC STENT DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6916910 ↗