Advanix™ Biliary M00533260Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729786634), received between Nov 12, 2018 and Dec 13, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionDec 13, 2023Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE STENT WAS KINKED. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THE STENT BARB WAS TORN. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317521 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS SUCCESSFULLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021 FOR TREATMENT/DRAINAGE OF LIVER CYST. IT WAS NOTED THAT THE STENT WAS DEPLOYED CORRECTLY, A LITTLE FAR OUT OF THE AMPULLA IN THE DUODENUM AND COMPLETED AT FOUR THIRTY IN THE AFTERNOON. AT TWO O'CLOCK IN THE MORNING, POST PROCEDURE, THE PATIENT HAD A DUODENAL PERFORATION AND WAS SENT BACK TO SURGERY. BASED ON THE PATIENT'S CHART, THE PATIENT HAD A SMALL FOCAL PERFORATION OF THE DUODENUM RESULTING FROM A STENT MIGRATION AT THE JUNCTION OF THE SECOND AND THIRD PORTION OF THE DUODENUM. THE PATIENT UNDERWENT SURGICAL INTERVENTION TO CLOSE THE DUODENAL PERFORATION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE AS "OKAY WITH NO FURTHER COMPLICATIONS REPORTED".

  Patient problems: Perforation

  MAUDE report 12511510 ↗
• InjuryApr 14, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. THE STENT WAS SUCCESSFULLY IMPLANTED WITHOUT ANY ISSUES. DURING ROUTINE FOLLOW-UP, ON (B)(6) 2021, IT WAS NOTICED THAT THE STENT HAD MIGRATED DISTALLY INTO THE DUODENAL WALL AND INTO THE COLON. THE PERFORATED DUODENUM WAS CLIPPED AND THE MIGRATED STENT WAS SUCCESSFULLY RETRIEVED USING A PAIR OF FORCEPS AND NO NEW STENT WAS IMPLANTED. 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 "FULLY RECOVERED".

  Patient problems: Perforation

  MAUDE report 11668594 ↗
• InjuryNov 12, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2018. ON (B)(6) 2018 THE PATIENT HAD THE ADVANIX BILIARY STENT IMPLANTED IN THE CBD WITH NO ISSUES REPORTED. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 DURING THE SCHEDULED STENT REMOVAL PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE ADVANIX BILIARY STENT USING A STANDARD POLYPECTOMY SNARE, PIECES APPEARED TO STRIP AWAY WITH MINOR RETRACTION OF THE SNARE. THE STENT TORE TANGENTIALLY ALONG ITS LENGTH FROM THE DISTAL FLANGE TO THE DISTAL TIP. THE PHYSICIAN MANAGED TO GRAB THE REMAINING STENT BODY AND REMOVE THIS WITH THE SNARE, ALONG WITH THE TORN OFF SECTION. ALL BROKEN PIECES OF STENT WERE REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE OK FOLLOWING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8059456 ↗