Advanix™ Pancreatic Stent M00537170Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729856641), received between Dec 27, 2017 and Sep 17, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC STENT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN ADVANIX PANCREATIC STENT WAS ADVANCED OVER A GUIDEWIRE INTO THE PATIENT, THE PHYSICIAN FELT RESISTANCE WHILE ATTEMPTING TO INSERT THE STENT. WHEN THE ENDOSCOPE SCREEN WAS CHECKED, THE STENT WAS FOUND TO BE KINKED. REPORTEDLY, THE STENT WAS REMOVED FROM THE PATIENT. A NEW ADVANIX PANCREATIC STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10547157 ↗
• InjurySep 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 5 FR ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE, PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT HAD A PANCREATIC FISTULA AND THE ANATOMY WAS VERY CHALLENGING DUE TO THE PANCREATIC DUCTAL ANATOMY, MAKING THE PROCEDURE DIFFICULT AND COMPLEX. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE 5 FR ADVANIX PANCREATIC STENT FAILED TO DEPLOY. THE 5 FR STENT WAS REMOVED FROM THE DUCT AND A 4 FR ADVANIX PANCREATIC STENT WAS INSERTED. DURING THE PLACEMENT OF THE 4 FR PANCREATIC STENT, FLUOROSCOPY REVEALED A SMALL PIECE OF MATERIAL WHICH WAS ASSUMED TO BE A MAGNETIC RESONANCE MARKER FROM THE 5 FR STENT. THE PIECE SEEN ON FLUOROSCOPY WAS THE SIZE OF A MARKER, BUT WAS UNABLE TO BE RETRIEVED. AN ANGLE-TIP GUIDEWIRE WAS USED TO SUCCESSFULLY DEPLOY THE 4 FR ADVANIX PANCREATIC STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PHYSICIAN EXAMINED THE 5 FR ADVANIX STENT AND NO PART APPEARED TO BE MISSING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10501211 ↗
• 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 7148572 ↗