AXIOS?
Report
- Report Number
- 3005099803-2025-04645
- Event Type
- Injury
- Date Received
- September 11, 2025
- Date of Event
- August 1, 2025
- Report Date
- January 13, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 00191506008086
- PMA / PMN Number
- K233318
- Removal / Correction Number
- 3005099803-12192025-004-
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6: IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF DEVICE CODE A090814 CAPTURES THE REPORTABLE EVENT OF STENT NOT VISIBLE UNDER EUS. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE DIFFICULT TO POSITION. IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND.
BLOCKS H7, H9 AND H11 HAVE BEEN UPDATED. BLOCK H6: IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF DEVICE CODE A090814 CAPTURES THE REPORTABLE EVENT OF STENT NOT VISIBLE UNDER EUS. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE DIFFICULT TO POSITION. IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. BLOCK H11: BOSTON SCIENTIFIC IS INITIATING A REMOVAL OF CERTAIN SIZES OF THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM (6MM X 8MM, 8MM X 8MM AND 20MM X 10MM) MANUFACTURED SINCE MARCH 1, 2025. THIS ACTION IS BEING TAKEN DUE TO INCREASED REPORTS OF STENT DEPLOYMENT AND EXPANSION ISSUES WITH THESE CONFIGURATIONS. THESE ISSUES ONLY OCCUR AT THE TIME OF STENT DELIVERY AND ARE EXPECTED TO BE NOTICED BY THE PHYSICIAN. PATIENTS WHO HAVE BEEN TREATED WITH A SUCCESSFULLY IMPLANTED AXIOS STENT SHOULD CONTINUE TO FOLLOW STANDARD OF CARE AND ARE NOT AFFECTED BY THIS ISSUE. A LETTER WAS SENT OUT TO MATERIALS MANAGERS/HEALTH CARE PROFESSIONALS ON 19-DEC-2025 TO IMMEDIATELY STOP FURTHER DISTRIBUTION OR USE OF ANY AFFECTED 6MM X 8MM, 8MM X 8MM AND 20MM X 10MM AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. THE LETTER INDICATES TO REMOVE THESE DEVICES FROM INVENTORY AND SEGREGATE THEM IN A SECURE LOCATION UNTIL THEY CAN BE RETURNED TO BOSTON SCIENTIFIC. THE REFERENCED AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM MET ALL SPECIFICATIONS PRIOR TO FINAL APPROVAL FOR DISTRIBUTIONS/SALE.
BLOCK B5 AND H6 WERE CORRECTED WITH EVENT DETAILS MISSING FROM PREVIOUS REPORT (OFF LABEL INFORMATION). BLOCK H6: IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF DEVICE CODE A090814 CAPTURES THE REPORTABLE EVENT OF STENT NOT VISIBLE UNDER EUS. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE DIFFICULT TO POSITION. IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO DRAIN THE BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND (EUS) CHOLEDOCHODUODENOSTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE ACCESS SITE WAS SMALL, AND THE GUIDEWIRE COULD NOT BE ADVANCED PROXIMALLY. THE INITIAL PUNCTURE WAS SUCCESSFUL; HOWEVER, THE IMAGE WAS UNCLEAR, AND FLANGE OPENING COULD NOT BE CONFIRMED. UPON TENTING, THE PHYSICIAN FELT THE DEVICE WAS SECURED. WHILE DEPLOYING THE EXTERNAL FLANGE, THE INTERNAL FLANGE WAS INADVERTENTLY PULLED THROUGH INTO THE SMALL BOWEL. THE PHYSICIAN SALVAGED THE DRAINAGE BY DEPLOYING A FULLY COVERED WALLFLEX STENT THROUGH THE AXIOS TRACT INTO THE DUCT AND PLACING A DOUBLE PIGTAIL STENT THROUGH IT. THEREFORE, THE PROCEDURE WAS COMPLETED USING THE AXIOS STENT, ASSISTED BY ADDITIONAL DIFFERENT DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO DRAIN THE BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND (EUS) CHOLEDOCHODUODENOSTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE ACCESS SITE WAS SMALL, AND THE GUIDEWIRE COULD NOT BE ADVANCED PROXIMALLY. THE INITIAL PUNCTURE WAS SUCCESSFUL; HOWEVER, THE IMAGE WAS UNCLEAR, AND FLANGE OPENING COULD NOT BE CONFIRMED. UPON TENTING, THE PHYSICIAN FELT THE DEVICE WAS SECURED. WHILE DEPLOYING THE EXTERNAL FLANGE, THE INTERNAL FLANGE WAS INADVERTENTLY PULLED THROUGH INTO THE SMALL BOWEL. THE PHYSICIAN SALVAGED THE DRAINAGE BY DEPLOYING A FULLY COVERED WALLFLEX STENT THROUGH THE AXIOS TRACT INTO THE DUCT AND PLACING A DOUBLE PIGTAIL STENT THROUGH IT. THEREFORE, THE PROCEDURE WAS COMPLETED USING THE AXIOS STENT, ASSISTED BY ADDITIONAL DIFFERENT DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING AN ENDOSCOPIC ULTRASOUND (EUS) CHOLEDOCHODUODENOSTOMY PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM OR LARGER IN SIZE AND WALLED-OFF NECROSIS 6 CM OR LARGER IN SIZE WITH AT LEAST 70% FLUID CONTENT, PROVIDED THEY ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE IMPLANTED BETWEEN THE COMMON BILE DUCT AND THE DUODENUM DURING A CHOLEDOCHODUODENOSTOMY PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO DRAIN THE BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND (EUS) CHOLEDOCHODUODENOSTOMY PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE ACCESS SITE WAS SMALL, AND THE GUIDEWIRE COULD NOT BE ADVANCED PROXIMALLY. THE INITIAL PUNCTURE WAS SUCCESSFUL; HOWEVER, THE IMAGE WAS UNCLEAR, AND FLANGE OPENING COULD NOT BE CONFIRMED. UPON TENTING, THE PHYSICIAN FELT THE DEVICE WAS SECURED. WHILE DEPLOYING THE EXTERNAL FLANGE, THE INTERNAL FLANGE WAS INADVERTENTLY PULLED THROUGH INTO THE SMALL BOWEL. THE PHYSICIAN SALVAGED THE DRAINAGE BY DEPLOYING A FULLY COVERED WALLFLEX STENT THROUGH THE AXIOS TRACT INTO THE DUCT AND PLACING A DOUBLE PIGTAIL STENT THROUGH IT. THEREFORE, THE PROCEDURE WAS COMPLETED USING THE AXIOS STENT, ASSISTED BY ADDITIONAL DIFFERENT DEVICES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED DURING AN ENDOSCOPIC ULTRASOUND (EUS) CHOLEDOCHODUODENOSTOMY PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS 6 CM OR LARGER IN SIZE AND WALLED-OFF NECROSIS 6 CM OR LARGER IN SIZE WITH AT LEAST 70% FLUID CONTENT, PROVIDED THEY ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE IMPLANTED BETWEEN THE COMMON BILE DUCT AND THE DUODENUM DURING A CHOLEDOCHODUODENOSTOMY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145106 | AXIOS? | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553680 | 0036603297 | 00191506008086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |