Advanix™ Biliary M00534350Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729787440), received between May 9, 2017 and Jan 20, 2026 — classified as 1 death, 14 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2026Entrapment of Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A BILE DUCT DRAINAGE IN THE MAIN BILE DUCT DURING A BILE DUCT DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE INTRODUCING THE STENT INTO THE OPERATING CHANNEL. DESPITE THE ORANGE PROTECTIVE COVER BEING IN PLACE OVER THE ERGOS, THE DEVICE COULD NOT BE ADVANCED. DURING THE ATTEMPT, ONE OF THE WIRES DETACHED AND BECAME LODGED INSIDE THE OPERATING CHANNEL. ANOTHER ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT BARB WAS TORN. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115751 ↗
• MalfunctionApr 2, 2025Break; Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TIGHT. DURING THE PROCEDURE, THE PULL WIRE WAS DIFFICULT TO RETRACT, AND THE STENT WAS UNABLE TO BE RELEASED. THE NURSE ATTEMPTED TO DEPLOY THE STENT AGAIN; HOWEVER, THE PULL WIRE GOT DETACHED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A REVIEW OF THE PHOTO PROVIDED BY THE COMPLAINANT SHOWED THAT THE PULL WIRE WAS BROKEN AND KINKED, AND THE PUSH CATHETER WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753690 ↗
• MalfunctionMar 6, 2025

  FROM STAFF: PATIENT IN AN ERCP [ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY]. PROVIDER WAS GOING TO INSERT STENT IN PATIENT AND WHEN EQUIPMENT WAS REMOVED FROM PACKAGING STENT WAS DETACHED. UNABLE TO USE. EQUIPMENT MALFUNCTION WAS NOTICED PRIOR TO PROCEEDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535689 ↗
• MalfunctionJul 17, 2024Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PULL WIRE DETACHED FROM THE GUIDE CATHETER, AND THE STENT WAS NOT ABLE TO BE DEPLOYED. ANOTHER ADVANIX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE DELIVERY SYSTEM DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "FOR PRELOADED SYSTEM ONLY: IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE ENDOSCOPE, THE STENT CANNOT BE FULLY DEPLOYED." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19764829 ↗
• InjuryJul 15, 2024Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DOUBLE BEND STENT WAS USED IN THE BILIARY DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE OFF REMAINING IN THE PROSTHESIS DURING THE ATTEMPTED RELEASE AND IT WAS SUBSEQUENTLY REMOVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY PRELOADED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE DELIVERY SYSTEM DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES," FOR PRELOADED SYSTEM ONLY: IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE ENDOSCOPE, THE STENT CANNOT BE FULLY DEPLOYED." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742907 ↗
• MalfunctionApr 30, 2024Break; Positioning Failure; Use of Device Problem; Material Deformation; Material Twisted/Bent; Break; Positioning Failure; Use of Device Problem; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOAD DUODENAL BEND STENT WAS USED IN THE BILIARY TREE TO TREAT A BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE STENT WAS DEPLOYED, IT WAS UNABLE TO BE RELEASED FROM THE CATHETER, BUT IT WAS ENTIRELY DEPLOYED ON THE HANDLE. UPON CHECKING THE ENDOSCOPIC IMAGE, IT WAS NOTED THAT THE SUTURE WAS WRAPPED AROUND THE FLANGE OF THE STENT. THE PHYSICIAN TRIED TO MANEUVER IT AWAY WHILE THE NURSE PULLED HARD TO DEPLOY BUT THE STENT WAS STILL UNABLE TO BE DEPLOYED. SUBSEQUENTLY, THE PHYSICIAN PULLED OUT THE SCOPE AND THE STENT; HOWEVER, IT WAS NOTED THAT THE GUIDE CATHETER WAS BROKEN INTO TWO PIECES AND WAS STUCK IN THE SCOPE. IT WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE DELIVERY SYSTEM DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "FOR PRELOADED SYSTEM ONLY: IF T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19217940 ↗
• MalfunctionFeb 9, 2024Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem

  PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY WAS TO BE IMPLANTED TO TREAT STRICTURES IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. EVENT SUMMARY: DURING PREPARATION, THE BLACK GUIDE CATHETER WAS STRETCHED. ANOTHER ADVANIX NAVIFLEX STENT WAS USED TO COMPLETE THE PROCEDURE. PATIENT STATUS: THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED/SEPARATED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18679232 ↗
• InjuryDec 11, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DUODNAL BEND STENT WAS IMPLANTED IN THE DUODENUM TO TREAT A MALIGNANT COMMON BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2023. DURING AN EMERGENT PATIENT FOLLOW-UP ON (B)(6), 2023, AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED TO ASSESS THE PATIENT'S UPPER GASTROINTESTINAL (GI) BLEEDING, AND IT WAS CONFIRMED THAT THE ADVANIX RX STENT HAD MIGRATED AND PERFORATED THE DISTAL SIDE OF THE DUODENAL WALL, WHICH CAUSED A PERFORATION. COMPUTED TOMOGRAPHY (CT) IMAGING WAS TAKEN, AND THE STENT WAS REMOVED USING FORCEPS. THE PERFORATION WAS CLOSED WITH A NON-BOSTON SCIENTIFIC CLIP. THE PATIENT WAS REPORTED TO HAVE BEEN ADMITTED TO THE HOSPITAL BEYOND THE STANDARD DAYS OF CARE AND HAS NOT BEEN DISCHARGED BUT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18303970 ↗
• MalfunctionNov 20, 2023Entrapment of Device; Positioning Problem; Material Split, Cut or Torn; Entrapment of Device; Positioning Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS TO BE USED IN THE DUODENUM, AMPULLA TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE TRAILING BARB GOT CAUGHT ON THE ELEVATOR OF THE SCOPE. THE PHYSICIAN ATTEMPTED TO PUSH THE TRAILING BARB OUT OF THE SCOPE; HOWEVER, IT WAS UNABLE TO BE REMOVED AND GOT TORN A BIT. THE STENT WAS REMOVED TOGETHER WITH THE SCOPE. THE PROCEDURE WAS COMPLETED USING ANOTHER ADVANIX-NAVIFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172219 ↗
• InjuryApr 18, 2023Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE USED TO TREAT BILIARY STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE DUCTUS CHOLEDOCHUS, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE ADVANIX BILIARY STENT WAS ATTEMPTED TO BE DEPLOYED, THE GUIDE CATHETER BROKE AND BECAME STUCK WITHIN THE PREVIOUSLY IMPLANTED METAL STENT (NON-BSC DEVICE). THE BROKEN GUIDE CATHETER WAS SUCCESSFULLY REMOVED FROM THE METAL STENT USING A GRASPING FORCEPS. THERE WERE NO ISSUES WITH THE METAL STENT AND PLACEMENT AS RESULT OF THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW ADVANIX BILIARY STENT. THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765836 ↗
• InjuryMar 17, 2023Migration; Device Stenosis; Migration; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT ONE ADVANIX BILIARY STENT AND ONE NON-BOSTON SCIENTIFIC (MANUFACTURER UNKNOWN) STENT WERE SUCCESSFULLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR BILIARY DRAINAGE PERFORMED ON (B)(6) 2021. ONE MONTH LATER, ON (B)(6) 2021, THE PATIENT WAS PRESENTED TO THE HOSPITAL WITH CHOLANGITIS. THE PATIENT WAS ADMITTED, AND THE CHOLANGITIS WAS TREATED WITH IV LEVOFLOXACIN AND FLAGYL. ON (B)(6) 2021, THE PATIENT UNDERWENT AN ERCP. DURING THE ERCP, THE STENTS PLACED ON (B)(6) 2021, WERE PARTIALLY OCCLUDED AND ONE WAS MIGRATED DISTALLY. THE STENTS WERE ORIGINALLY PLACED IN THE BILIARY TREE WERE EMERGING FROM THE MAJOR PAPILLA. BOTH THE ADVANIX BILIARY STENT AND NON-BOSTON SCIENTIFIC (MANUFACTURER UNKNOWN) STENT WERE REMOVED WITH FORCEPS AND TWO NEW ADVANIX BILIARY STENTS WERE PLACED, ONE IN THE RIGHT ANTERIOR HEPATIC DUCT AND ONE IN THE RIGHT POSTERIOR HEPATIC DUCT. ON (B)(6) 2021, THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2021, THE PATIENT RETURNED WITH SYMPTOMS SIMILAR TO THE HOSPITALIZATION ON (B)(6) 2021. THE CT SCAN SHOWED STENTS IN PLACE WITH POSSIBLE MILDLY DISTALLY MIGRATED STENT. OTHER THAN OVERNIGHT ST

  Patient problems: Cholangitis

  MAUDE report 16567983 ↗
• DeathFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX RX BILIARY STENT WAS PLACED SUCCESSFULLY ON (B)(6), 2022. ON (B)(6), 2022, THE PATIENT PASSED AWAY. RELATION TO THE STENT PLACEMENT WAS NOT SPECIFIED. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 3, 2023: THE PHYSICIAN CLARIFIED THAT THERE WAS NO RELATIONSHIP BETWEEN THE ADVANIX RX BILIARY STENT AND THE PATIENT DEATH. THE PATIENT WAS ON PALLIATIVE STATUS (PS) AND THE PATIENT CAUSE OF DEATH WAS LETHAL EVOLUTION OF TUMORAL DISEASE. THE SEQUENCE OF EVENTS LEADING UP TO THE PATIENT DEATH WERE END OF LIFE OF TUMORAL DISEASE WITH OCCLUSION SYNDROME AND PALLIATIVE CARE. ADDITIONALLY, THE PHYSICIAN NOTED THAT THE STENT WAS PLACED AS BILIARY DRAINAGE FOR METASTATIC CHOLANGITIS, THE STENT WAS NOT EXPLANTED PRIOR TO THE PATIENT DEATH AND THE PATIENT STATUS AT THE CLOSE OF THE STENT PLACEMENT PROCEDURE WAS PS 2-3. THE PATIENT HAD A HISTORY OF ADENOCARCINOMA OF THE CARDIA, TREATED BY RADIATION CHEMOTHERAPY TREATMENT (RCT), SURGERY AND IMMUNOTHERAPY, AND PROSTATE ADENOCARCINOMA.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293238 ↗
• MalfunctionFeb 3, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE BILE DUCT PERFORMED ON (B)(6) 2022. DURING PREPARATION, IT WAS NOTICED THAT THE SUTURE WIRE THAT HOLDS THE STENT TO THE DELIVERY SYSTEM WAS BROKEN. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THE STENT BARB WAS TORN, THEREFORE THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16292533 ↗
• InjuryDec 8, 2022Obstruction of Flow; Migration; Obstruction of Flow; Migration

  THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT #3005099803-2022-07113). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER WORKUP. THE PATIENT WAS TREATED WITH ZOSYN FOR SUSPECTED CHOLANGITIS. THE PATIENT HAD A CT-SCAN IN THE EMERGENCY DEPARTMENT, AND IT SHOWED THAT THE STENT MIGRATED FROM THE RIGHT PORTAL BILIARY DUCT INTO THE COMMON BILE DUCT. ON (B)(6) 2021, AN ERCP PROCEDURE WAS PERFORMED FOR STENT REMOVAL. DURING THE PROCEDURE, IT WAS NOTED THAT TWO STENTS MIGRATED AND WERE OBSTRUCTED. BOTH STENTS WERE SUCCESSFULLY REMOVED IN THIS PROCEDURE. IT WAS REPORTED THAT TWO STENTS, ONE OF THE SAME MODEL AND OTHER OF A DIFFERENT MODEL WERE SUCCESSFULLY PLACED AND HAVE COMPLETED THE PROCEDURE. ON THE FOLLOWING DAY, POST PROCEDURE, THE PATIENT HAD EXPERIENCED A SLIGHT INCREASED ABDOMINAL PAIN. THE INCREASED FATIGUE WAS SUSPECTED TO BE SECONDARY TO THE PROCEDURE VERSUS ACUTE PANCREATITIS. THE CONDITION OF THE PATIENT WAS REPORTED TO HA

  Patient problems: Cholangitis; Fatigue

  MAUDE report 15941014 ↗
• InjuryNov 30, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2022. POST PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022 TO UNDERGO AN ERCP PROCEDURE. ON (B)(6) 2022, THE PROCEDURE WAS PERFORMED FOR STENT REMOVAL. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT WAS PARTIALLY OCCLUDED AND CHOLANGITIS WAS NOTED. SLUDGE/PUS WAS CLEARED FROM THE DUCTS, DRAINAGE AND OPACITIES FROM HDS, AND RFA WAS PERFORMED. ANOTHER STENT OF A DIFFERENT MODEL WAS IMPLANTED TO THE PATIENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 AND WAS GIVEN FLAGYL/CIPRO FOR CHOLANGITIS TREATMENT.

  Patient problems: Cholangitis

  MAUDE report 15887524 ↗
• MalfunctionOct 25, 2022Obstruction of Flow; Device Stenosis; Obstruction of Flow; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT WAS OCCLUDED. A BLOOD CLOT WAS NOTICED IN THE STENT. THERE WAS NO INFORMATION ON WHAT STENT COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 27, 2022: DURING A STENT REMOVAL AND PLACEMENT PROCEDURE, THE STENT WAS DEPLOYED IN THE COMMON BILE DUCT, HOWEVER, IT WAS NOTED THAT THE STENT WAS OCCLUDED, AND BLOOD CLOT WAS NOTICED. THE STENT WAS REMOVED USING A SNARE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. IT WAS REPORTED THAT WHEN THE PREVIOUS STENT WAS REMOVED VIA SNARE, THERE WAS A MODERATE AMOUNT OF BLEEDING AND THEN THE NEW STENT WAS PUT IN WHICH IS HOW THE STENT WAS FILLED WITH THE BLOOD. THERE WAS NOTHING MENTIONED IN THE NOTE ABOUT ANY ADDITIONAL TREATMENTS OR INTERVENTIONS FOR THE BLEEDING THAT HAPPENED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15664913 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS IMPLANTED IN THE BILE DUCT ON AN UNKNOWN DATE. DURING THE EMERGENT FOLLOW UP, WITHIN 24 HOURS AFTER THE STENT WAS IMPLANTED, THE PATIENT RETURNED TO THE EMERGENCY ROOM, IT WAS NOTICED THAT THE STENT HAD PERFORATED THE OPPOSITE DUODENAL WALL AND IT WAS CONFIRMED VIA ENDOSCOPY. AN UNPLANNED STENT REMOVAL WAS PERFORMED. IT WAS REPORTED THAT THE STENT HAD BEEN UP INTO THE RIGHT AND LEFT HEPATIC, IT HELD THE STENT IN PLACE AND WAS MORE RIGID OUTSIDE THE PAPILLA. ALSO, THE PHYSICIAN USED A 10FR BY 12CM STENT AND REALIZED THAT 10FR BY 12CM STENT WAS TOO LONG, AND THE MATERIAL OF THE PLASTIC STENT WAS CAPABLE OF PERFORATING THE DUODENAL WALL. THE STENT WAS REMOVED FROM THE PATIENT AND THE PERFORATED DUODENAL WALL WAS CLOSED WITH SUTURES. THERE WAS NO NEW DEVICE IMPLANTED. THE PATIENT'S CONDITION FOLLOWING THE REMOVAL PROCEDURE IS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 15383977 ↗
• InjurySep 20, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC ULTRASOUND/ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE PAPILA PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PUSH CATHETER WAS BROKEN INTO TWO OR MORE PIECES. THE BROKEN PIECES WERE SUCCESSFULLY REMOVED WITH RAT TOOTH FORCEPS. IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE PLACED. THERE WERE NO SERIOUS INJURIES NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12499703 ↗
• MalfunctionJun 28, 2021Component Missing; Component Missing

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMNON BILE DUCT. THE EXACT EVENT DATE WAS NOT PROVIDED. DURING THE PROCEDURE, WHEN THE STENT WAS INSERTED INTO THE BILE DUCT, IT WAS FOUND THAT THE RO MARKER BAND AT THE TIP OF THE GUIDE CATHETER WAS MISSING. IT WAS NOTED THAT THE END OF THE EXAMINATION, THE ENTIRE DELIVERY SYSTEM AND THE DEFECTIVE PROSTHESIS WERE RADIOED AGAIN FOR CONTROL AND NO RADIO OPAQUE MARKINGS APPEARED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12077530 ↗
• MalfunctionJun 15, 2021Break; Entrapment of Device; Appropriate Device Problem Term/Code Not Available; Break; Entrapment of Device; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT IS ONE OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2021-02498, MFR. REPORT # 3005099803-2021-02500 AND MFR. REPORT # 3005099803-2021-02501). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN DELIVERED THE ADVANIX 12CM 10FR STENT INTO THE BILE DUCT, THE PHYSICIAN THAT THE STENT WAS TOO LONG AND NEEDED A SHORTER 9CM STENT. THE UNDEPLOYED ADVANIX-NAVIFLEX WAS REMOVED WITH SUTURE ATTACHED INTO SCOPE TO BE EXCHANGED WITH ANOTHER SHORTER 8.5FR 9CM ADVANIX PRELOADED STENT. THE PHYSICIAN ATTEMPTED TO INSERT THE 9CM STENT BUT STILL STRUGGLED TO COME OUT OF THE SCOPE INTO THE DUODENUM AND SO THEN EXCHANGED FOR ANOTHER 9CM 8.5 FR ADVANIX PRELOADED STENT WHICH ALSO STRUGGLED TO EXIT THE SCOPE. BOTH 9CM 8.5 FR ADVANIX PRELOADED STENT WAS ALSO REMOVED AND THEN IT WAS DISCOVERED THAT THE ORIGINAL 10FR 12CM STENT WAS DETACHED FROM THE DELIVERY SYSTEM IN THE SCOPE AND THE SUTURE STRING WAS BROKEN DURING REMOVAL AND WAS NOT NOTICED. THE ADVANIX 12CM 10FR STENT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005692 ↗
• InjuryJan 6, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2020. THE EXACT IMPLANT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PATIENT REGULAR CHECKUP, IT WAS NOTICED THAT THE STENT HAD MIGRATED DISTALLY AND PERFORATED THE DUODENAL WALL OF THE PATIENT. THE PERFORATION WAS CONFIRMED THROUGH ENDOSCOPY. THE PHYSICIAN WAS ABLE TO REMOVE THE STENT FROM THE PATIENT USING GRASPERS. NO NEW STENT WAS REPORTED TO REPLACE THE MIGRATED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 11127473 ↗
• InjurySep 11, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS REMOVED FROM THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. THE ADVANIX BILIARY STENT WAS IMPLANTED APPROXIMATELY 30 TO 45 DAYS. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL, THE IMPLANTED STENT WAS FOUND TO HAVE MIGRATED DISTALLY AND ERODED INTO THE DUODENAL WALL. THE EROSION WAS CLOSED WITH THE USE OF A SCOPE CLIP. REPOPRTEDLY, THE STENT DID NOT BREAK AND WAS REMOVED SUCCESSFULLY USING GRASPERS . THERE WAS NO NEW STENT IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Perforation

  MAUDE report 10522609 ↗
• InjuryJun 18, 2020Break; Migration; Break; Migration

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2020-02322 AND MFR. REPORT # 3005099803-2020-02327). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX-NAVIFLEX BILIARY STENT WAS EXPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH A HURRICANE RX DILATATION BALLOON IN THE COMMON BILE DUCT PERFORMED ON ON (B)(6) 2020. ON (B)(6) 2020 THE STENT WAS IMPLANTED SUCCESSFULLY. NO ISSUES WERE REPORTED WITH THE DEVICE DURING PLACEMENT. ON (B)(6) 2020, THE STENT WAS FOUND TO HAVE MIGRATED DISTALLY 3 TO 4 CM FROM THE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE UNPLANNED STENT REMOVAL PROCEDURE, A SNARE WAS USED TO RETRIEVE THE STENT. A HURRICANE BALLOON WAS THEN USED FOR DILATION TO IMPLANT A NEW ADVANIX 15CM 10FR STENT; HOWEVER, THE STENT WAS DIFFICULT TO ADVANCE IN THE ANATOMY. THE DILATION WAS REPEATED; HOWEVER, APPROXIMATELY 10 CM LONG OF A BLACK PIECE OF PLASTIC SEEMED TO BE A RADIOPAQUE WAS NOTED IN THE COMMON BILE DUCT WHEN THE HURRICANE BALLOON WAS WITHDRAWN FROM THE PATIENT. REPORTEDLY, THE DETACHED BLACK PLASTIC PIECE WAS RETRIEVED THROUGH THE SCOPE USING A SNARE. ANOTHER

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10169043 ↗
• MalfunctionDec 17, 2019Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, SEVERE RESISTANCE WAS NOTICED AND THE STENT FAILED TO DEPLOY. REPORTEDLY, THE DUCT WAS DILATED BECAUSE OF STONES. ANOTHER ADVANIX-NAVIFLEX STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481572 ↗
• InjuryJun 27, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THEY ATTEMPTED TO DEPLOY THE ADVANIX BILIARY STENT IN THE MIDDLE PART OF THE CHOLEDOCHUS, THE STENT WAS BROKEN INTO PIECES. THE BROKEN STENT WAS REMOVED FROM THE PATIENT WITH THE USE OF SNARE. 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 AND OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739763 ↗