Advanix™ Pancreatic Stent M00536630Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729857570), received between Jan 3, 2017 and Apr 1, 2022 — classified as 2 injuries, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS OPENED TO BE USED DURING A PROCEDURE IN THE PANCREATIC DUCT. THE PROCEDURE NAME AND DATE WAS NOT REPORTED. DURING THE PROCEDURE, WHEN THE ADVANIX PANCREATIC STENT WAS UNPACKED, IT WAS FOUND KINKED. 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 AS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977931 ↗
• InjuryOct 20, 2020Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMMERCIAL BSC PLASTIC STENT WAS IMPLANTED IN THE BILE DUCT OF A PATIENT ON (B)(6) 2013 AS PART OF THE E7058 WF BILIARY FC CHRONIC PANC RCT CLINICAL STUDY. ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSPITAL IN PREPARATION FOR THE STENT PLACEMENT PROCEDURE. THE PATIENT UNDERWENT A BASELINE ASSESSMENT OF BILIARY OBSTRUCTIVE SYMPTOMS, AND NO SYMPTOMS WERE IDENTIFIED. ON (B)(6) 2013, THE PATIENT UNDERWENT THE STUDY STENT PLACEMENT PROCEDURE. A PRIOR BILIARY SPHINCTEROTOMY HAD BEEN PERFORMED. PROPHLYACTIC ANTIBIOTICS WERE ADMINISTERED. DURING THE STENT PLACEMENT, A 10FR X 7CM BSC PLASTIC STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. ON (B)(6) 2013, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO REPORTED ISSUES. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN. ON (B)(6) 2014, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ABDOMINAL PAIN. ON (B)(6) 2013, THE PATIENT UNDERWENT A STENT EXCHANGE PROCEDURE WHERE SLUDGE WAS REMOVED FROM THE PATIENT'S STENT. NO ADDITIONAL STENTS WERE REPORTEDLY IMPLANTED DURING THE STENT EXCHANGE PROCEDURE, NOR WERE ANY STEN

  Patient problems: Inflammation; No Code Available

  MAUDE report 10706573 ↗
• InjuryOct 20, 2020Use of Device Problem; Migration; Use of Device Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A COMMERCIAL BSC PLASTIC STENT WAS IMPLANTED IN THE BILE DUCT OF A PATIENT ON (B)(6) 2013 AS PART OF THE E7058 WF BILIARY FC CHRONIC PANC RCT CLINICAL STUDY. ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSPITAL IN PREPARATION FOR THE STENT PLACEMENT PROCEDURE. THE PATIENT UNDERWENT A BASELINE ASSESSMENT OF BILIARY OBSTRUCTIVE SYMPTOMS AND NO SYMPTOMS WERE IDENTIFIED. ON (B)(6) 2013, THE PATIENT UNDERWENT THE STUDY STENT PLACEMENT PROCEDURE. A PRIOR BILIARY SPHINCTEROTOMY HAD BEEN PERFORMED. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. DURING THE STENT PLACEMENT, A 10FR X 7CM BSC PLASTIC STENT WAS DEPLOYED IN A SATISFACTORY POSITION ACROSS THE STRICTURE. ON (B)(6) 2013 THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH NO REPORTED ISSUES. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014 THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN. ON (B)(6) 2014 THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ABDOMINAL PAIN. ON (B)(6) 2014 THE PATIENT UNDERWENT A STENT EXCHANGE PROCEDURE WHERE SLUDGE WAS REMOVED FROM THE PATIENT'S STENT. NO ADDITIONAL STENTS WERE REPORTEDLY IMPLANTED DURING THE STENT EXCHANGE PROCEDURE, NOR WERE ANY STENTS RE

  Patient problems: Inflammation; No Code Available

  MAUDE report 10705055 ↗
• MalfunctionApr 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS FOUND THAT THE TIP OF THE ADVANIX PANCREATIC STENT WAS KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8491390 ↗
• MalfunctionJan 3, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ PANCREATIC STENT WAS USED DURING A PANCREATIC DUCTAL STENT PLACEMENT PROCEDURE PERFORMED IN THE PANCREATIC DUCT ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING INSERTION, RESISTANCE WAS FELT AND THE ADVANIX¿ PANCREATIC STENT DID NOT COME OUT FROM THE FORCEPS CHANNEL OF THE ENDOSCOPE. THE ENDOSCOPE WAS REMOVED FROM THE PATIENT. WHEN ATTEMPTING TO REMOVE THE STENT FROM THE SCOPE, THE PHYSICIAN REPORTED THAT THERE WAS A ¿WHITE OBJECT¿ ATTACHED TO THE FLAP OF THE STENT. THE PHYSICIAN ASSESSED THAT THIS MAY HAVE BEEN THE CAUSE OF THE RESISTANCE MET DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 6217938 ↗