AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2025-06088
- Event Type
- Malfunction
- Date Received
- November 17, 2025
- Date of Event
- October 24, 2025
- Report Date
- January 14, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QXH
- UDI-DI
- 08714729904540
- PMA / PMN Number
- K150692
- Removal / Correction Number
- 3005099803-12192025-004-
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B5: UPDATED EVENT DESCRIPTION. BLOCK H6: 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 H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND.
BLOCK B5: UPDATED EVENT DESCRIPTION BLOCK H6: 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 IN THE BILE DUCT TO FACILITATE DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL FLANGE DID NOT OPEN, AND IT WAS REPORTED THAT THE PROCESSING TIME WAS EXTENDED ABOUT 20 MINUTES. AS A RESULT, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME. NOTE: THE COMPLAINANT HAS ATTACHED IMAGES SHOWING THE DEVICE POUCH WITH STENT INFORMATION, AS WELL AS THE STENT WITHIN THE PATIENT'S ANATOMY, AND IT COULD BE OBSERVED THAT THE DISTAL FLANGE DID NOT OPEN AS INTENDED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE BILE DUCT TO FACILITATE DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL FLANGE DID NOT OPEN, AND IT WAS REPORTED THAT THE PROCESSING TIME WAS EXTENDED. HOWEVER, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME. NOTE: THE COMPLAINANT HAS ATTACHED IMAGES SHOWING THE DEVICE POUCH WITH STENT INFORMATION, AS WELL AS THE STENT WITHIN THE PATIENT'S ANATOMY, AND IT COULD BE OBSERVED THAT THE DISTAL FLANGE DID NOT OPEN AS INTENDED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED IN THE BILE DUCT TO FACILITATE DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DISTAL FLANGE DID NOT OPEN, AND IT WAS REPORTED THAT THE PROCESSING TIME WAS EXTENDED ABOUT 20 MINUTES. AS A RESULT, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME. NOTE: THE COMPLAINANT HAS ATTACHED IMAGES SHOWING THE DEVICE POUCH WITH STENT INFORMATION, AS WELL AS THE STENT WITHIN THE PATIENT'S ANATOMY, AND IT COULD BE OBSERVED THAT THE DISTAL FLANGE DID NOT OPEN AS INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119407 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM | QXH | BOSTON SCIENTIFIC CORPORATION | M00553520 | 0037469758 | 08714729904540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |