Advanix™ Pancreatic Stent M00536540Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729857488), received between Feb 14, 2017 and Jul 18, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2025Material Deformation; Material Deformation

  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 PROCEDURE PERFORMED ON (B)(6) 2025. DURING PREPARATION, ONE SIDE OF THE FLAP WAS FOUND BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF A DIFFERENT MODEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543433 ↗
• MalfunctionMar 21, 2024Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE FLAP OF THE STENT WAS BENT UPON INSERTION, AND THE STENT COULD NOT BE PLACED PROPERLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948903 ↗
• MalfunctionJun 26, 2023Entrapment of Device; Premature Activation; Material Deformation; Entrapment of Device; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX PANCREATIC STENT WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC PANCREATIC STENT PLACEMENT PROCEDURE, PERFORMED ON (B)(6)2022. DURING THE PROCEDURE, OUTSIDE THE PATIENT, WHEN THE DEVICE WAS BEING INSERTED INTO THE ENDOSCOPE, IT BECAME STUCK AND WAS DIFFICULT TO PUSH THROUGH. IT WAS NOTED THAT THE DEVICE WAS DETACHED AND REMAINED INSIDE THE SCOPE. THE DEVICE WAS REMOVED FROM THE FORCEPS PORT BUT COULD NOT BE USED DUE TO DAMAGE AS THE DEVICE HAD BECOME FLATTENED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE AS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17201179 ↗
• MalfunctionApr 5, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX PANCREATIC STENT WAS BEING REMOVED FROM A PATIENT DURING AN ENDOSCOPIC PANCREATIC DUCT STENT REPLACEMENT PROCEDURE FROM THE BILE DUCT PERFORMED ON (B)(6) 2022. DURING THE PLANNED STENT REPLACEMENT PROCEDURE, A PAIR OF GRASPING FORCEPS WAS USED TO REMOVE THE PREVIOUSLY IMPLANTED STENT, HOWEVER, IT BECAME SEPARATED. IT WAS REPORTED THAT THE BROKEN STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND ANOTHER ADVANIX PANCREATIC STENT WAS IMPLANTED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014053 ↗
• MalfunctionJun 23, 2021Device Difficult to Setup or Prepare; Material Deformation; Device Difficult to Setup or Prepare; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A STENT POSITIONING PROCEDURE IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THEY COULD NOT POSITION THE STENT OVER THE GUIDEWIRE. IT WAS REPORTED THAT THE STENT WAS KINKED DURING PREPARATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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 NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050166 ↗
• MalfunctionMar 27, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED THAT THE SEAL ATTACHED IN THE STERILE POUCH WAS OPENED UPON INSPECTION. THE PACKAGING SEAL WAS STUCK ON THE PUSHER. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9889559 ↗
• MalfunctionDec 7, 2018Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED IN A PANCREATIC DUCT STENT PLACEMENT PERFORMED IN THE PANCREATIC DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, WHEN THEY ATTEMPTED TO PLACE THE 7FR 9CM ADVANIX PANCREATIC STENT FOR CHRONIC PANCREATITIS, THE STENT KINKED WHICH CAUSES THE DEPLOYMENT FAILURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AS DIFFERENT MANUFACTURER AND DIFFERENT SIZE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8142973 ↗
• MalfunctionSep 14, 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 CHOLANGIOPANCREOTOGRAPHY (ERCP) PROCEDURE IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE ADVANIX PANCREATIC STENT WAS PLACED IN THE PANCREATIC DUCT, SEVERE RESISTANCE WAS ENCOUNTERED WHEN THE STENT WAS RELEASED. THE DEVICE WAS DEPLOYED EVENTUALLY, HOWEVER THE PART OF THE STENT WAS EXPOSED TO THE PAPILLA SIDE OF THE PANCREATIC DUCT AND WHEN THE STENT WAS ATTEMPTED TO PULL SLIGHTLY, THE STENT KINKED. 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 7877693 ↗
• MalfunctionSep 14, 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 PANCREATIC DUCT PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE ADVANIX PANCREATIC STENT WAS PLACED IN THE PANCREATIC DUCT, SEVERE RESISTANCE WAS ENCOUNTERED WHEN THE STENT WAS RELEASED. THE DEVICE WAS DEPLOYED EVENTUALLY, HOWEVER THE PART OF THE STENT WAS EXPOSED TO THE PAPILLA SIDE OF THE PANCREATIC DUCT AND WHEN THE STENT WAS ATTEMPTED TO PULL SLIGHTLY, THE STENT KINKED. 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 7877687 ↗
• MalfunctionJan 4, 2018Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ PANCREATIC STENT WAS PLACED INTO DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THE STENT WAS INSERTED ENDOSCOPICALLY INTO THE PANCREATIC DUCT THROUGH THE GUIDEWIRE, HOWEVER SEVERE RESISTANCE WAS FELT AT THE MID-WAY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX¿ PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT KINKED/BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7165804 ↗
• 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 7148570 ↗
• MalfunctionFeb 14, 2017Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMMERCIAL BSC PLASTIC STENT WAS IMPLANTED IN THE PANCREATIC DUCT OF A PATIENT ON (B)(6) 2015 AS PART OF THE (B)(6) STUDY. ON (B)(6) 2015, THE PATIENT UNDERWENT THE STUDY STENT PLACEMENT PROCEDURE. AN INTRAPROCEDURAL PANCREATOGRAM WAS RECORDED JUST BEFORE STENT PLACEMENT. A PRIOR BILIARY AND PANCREATIC SPHINCTEROTOMY HAD BEEN PERFORMED. THE PANCREATIC DUCT WAS DILATED 4MM AND THE STENT IS INTENDED TO BE INDWELL FOR MORE THAN 8 WEEKS. DURING THE STENT PLACEMENT, A 9 CM 7 FR STRAIGHT WITH LEADING BARBS ADVANIX STENT WITH LOT NUMBER 18134488 WAS PLACED IN A SATISFACTORY MANNER. OVERALL EASE OF PLACEMENT WAS POOR, STENT PUSHABILITY WAS VERY POOR AND VISUALIZED FLUOROSCOPICALLY WAS GOOD. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, IT WAS NOTICED THAT THE STUDY STENT WAS KINKED HOWEVER IT WAS PLACED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6327969 ↗