Advanix™ Biliary M00532180Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729786979), received between Oct 8, 2019 and Jul 9, 2024 — classified as 1 injury, 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 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.

• MalfunctionJul 9, 2024Break; Positioning Failure; Deformation Due to Compressive Stress; Material Deformation; Break; Positioning Failure; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY DOUBLE PIGTAIL STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A COMMON BILE DUCT STONE DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDE CATHETER COULD NOT BE DEPLOYED. ANOTHER ADVANIX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVEN. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE PUSH CATHETER WAS TORN, AND THAT THE STENT WAS TORN AND BENT. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19707128 ↗
• MalfunctionNov 5, 2020Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  BOSTON SCIENTIFIC CORPORATION RECEIVED SIX COMPLAINTS REGARDING SIX SEPARATE ADVANIX BILIARY STENT DEVICES INVOLVED IN SEPARATE PROCEDURES ON DIFFERENT PATIENTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SIX ADVANIX BILIARY STENTS WERE USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES PERFORMED IN THE COMMON BILE DUCT OF SIX DIFFERENT PATIENTS. THE SIX PROCEDURES WERE PERFORMED ON BETWEEN AUGUST 1, 2020 TO AUGUST 30, 2020. HOWEVER, THE EXACT IMPLANT DATES WERE NOT REPORTED. THE SIX PATIENTS UNDERWENT PLANNED STENT REMOVAL PROCEDURES PERFORMED BETWEEN SEPTEMBER 15, 2020 AND OCTOBER 11, 2020. THE EXACT PROCEDURE DATES WERE NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURES, THE PHYSICIAN FOUND THAT A DOUBLE PIGTAIL STENT HAD MIGRATED PROXIMALLY IN THE DUODENUM FOR EACH CASE. THE DEVICES WERE REMOVED AND THE PROCEDURES WERE CANCELLED/RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. EACH PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791146 ↗
• MalfunctionOct 28, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX NAVIFLEX BILIARY STENT WAS BEING USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE DUODENAL PAPILLA PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING INTRODUCTION, OUTSIDE THE PATIENT, THE STENT COULD NOT CROSS THE ADVANCER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY 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 STABLE. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DAMAGED THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10748883 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS REMOVED FROM A PATIENT DURING A PLANNED STENT REMOVAL PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON APPROXIMATELY TWO TO THREE WEEKS FOLLOWING THE STENT PLACEMENT PROCEDURE. THE STENT WAS IMPLANTED ON (B)(6) 2019 WITHOUT ANY ISSUES REPORTED. ACCORDING TO THE COMPLAINANT, APPROXIMATELY TWO TO THREE WEEKS FOLLOWING THE STENT PLACEMENT PROCEDURE, A PLANNED STENT REMOVAL WAS PERFORMED. THE PHYSICIAN NOTICED THAT THE STENT PERFORATED THE COMMON BILE DUCT OF THE PATIENT. THE STENT WAS RETRIEVED USING FORCEPS AND THE PROCEDURE WAS COMPLETED. 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. ADDITIONAL INFORMATION RECEIVED ON 21OCT2019. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: Perforation

  MAUDE report 9167218 ↗