AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2025-03042
- Event Type
- Injury
- Date Received
- July 2, 2025
- Date of Event
- May 30, 2025
- Report Date
- January 13, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- PCU
- UDI-DI
- 08714729904557
- PMA / PMN Number
- K150692
- Removal / Correction Number
- 3005099803-12192025-004-
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT DEPLOYMENT PROBLEM DURING BILIARY DRAINAGE PROCEDURES. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON JULY 02, 2025.
BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT DEPLOYMENT PROBLEM DURING BILIARY DRAINAGE PROCEDURES. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.
BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT DEPLOYMENT PROBLEM DURING BILIARY DRAINAGE PROCEDURES. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. BLOCK H7 AND H9: ADDED TYPE OF REMEDIAL ACTION AND THE CORRECTION/REMOVAL REPORTING # INFORMATION. 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.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT FOR BILIARY DRAINAGE DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO OPEN THE FIRST FLANGE; HOWEVER, THIS WAS NOT POSSIBLE. THE PHYSICIAN THEN TRIED TO REPOSITION THE CATHETER, BUT THIS DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JULY 02, 2025. THE DUPLICATE MDR RECORD IS REPORT NUMBER 3005099803-2025-03045.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT FOR BILIARY DRAINAGE DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO OPEN THE FIRST FLANGE; HOWEVER, THIS WAS NOT POSSIBLE. THE PHYSICIAN THEN TRIED TO REPOSITION THE CATHETER, BUT THIS DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS 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 TO BE IMPLANTED IN THE BILE DUCT FOR BILIARY DRAINAGE DURING A PROCEDURE PERFORMED ON (B)(6) 2025 DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO OPEN THE FIRST FLANGE; HOWEVER, THIS WAS NOT POSSIBLE. THE PHYSICIAN THEN TRIED TO REPOSITION THE CATHETER, BUT THIS DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JULY 02, 2025. THE DUPLICATE MDR RECORD IS REPORT NUMBER 3005099803-2025-03045.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142211 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | PANCREATIC STENT, COVERED, METALLIC, REMOVABLE | PCU | BOSTON SCIENTIFIC CORPORATION | M00553530 | 0036191222 | 08714729904557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |