AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2025-06679
- Event Type
- Malfunction
- Date Received
- December 11, 2025
- Date of Event
- November 1, 2025
- Report Date
- January 14, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- QXH
- UDI-DI
- 08714729904540
- PMA / PMN Number
- K150692
- Removal / Correction Number
- H9: 3005099803-12192025-
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
NEW INFORMATION WAS RECEIVED CLARIFYING THE DESCRIPTION OF THE EVENT. IT WAS SPECIFIED THAT THE ISSUE INVOLVED DIFFICULTY WITH DEVICE EXPANSION. DESPITE THIS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE, WHICH CONTINUES TO FUNCTION CORRECTLY. THEREFORE, THIS EVENT IS NOW CONSIDERED NON-REPORTABLE, AS THE HAZARD ANALYSIS IDENTIFIES THE SPECIFIC HARMS ASSOCIATED WITH THIS HAZARD AND CONCLUDES THAT THE EVENT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY SHOULD IT OCCUR. 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 (B)(6) 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: UPDATED EVENT DESCRIPTION. BLOCK H6: UPDATED CODING SECTION. NEW INFORMATION WAS RECEIVED CLARIFYING THE DESCRIPTION OF THE EVENT. IT WAS SPECIFIED THAT THE ISSUE INVOLVED DIFFICULTY WITH DEVICE EXPANSION. DESPITE THIS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME DEVICE, WHICH CONTINUES TO FUNCTION CORRECTLY. THEREFORE, THIS EVENT IS NOW CONSIDERED NON-REPORTABLE, AS THE HAZARD ANALYSIS IDENTIFIES THE SPECIFIC HARMS ASSOCIATED WITH THIS HAZARD AND CONCLUDES THAT THE EVENT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY SHOULD IT OCCUR.
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 TRANSDUODENAL TO TREAT A TUMOR THROUGH BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, A MALFUNCTION IN THE OPENING OF THE FIRST FLANGE OCCURRED, IT HAD SOME DEPLOYMENT DIFFICULTIES. 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.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSDUODENAL TO TREAT A TUMOR THROUGH BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, A MALFUNCTION IN THE OPENING OF THE FIRST FLANGE OCCURRED, IT HAD SOME DEPLOYMENT DIFFICULTIES. 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.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSDUODENAL TO TREAT A TUMOR THROUGH BILIARY DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, A MALFUNCTION IN THE OPENING OF THE FIRST FLANGE OCCURRED, IT FAILED TO OPEN. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2159141 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | GALLBLADDER DRAINAGE STENT AND DELIVERY SYSTEM | QXH | BOSTON SCIENTIFIC CORPORATION | M00553520 | 0036621584 | 08714729904540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |