AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2025-06548
- Event Type
- Injury
- Date Received
- December 2, 2025
- Date of Event
- November 6, 2025
- Report Date
- January 14, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729951100
- PMA / PMN Number
- K233318
- Removal / Correction Number
- H9: 3005099803-12192025-
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF PATIENT CODE E014302 CAPTURES THE REPORTABLE EVENT OF DECREASED LEVEL OF CONSCIOUSNESS. IMDRF PATIENT CODE E0752 CAPTURES THE REPORTABLE EVENT OF RESPIRATORY ISSUES. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE.
BLOCK H6: IMDRF PATIENT CODE E014302 CAPTURES THE REPORTABLE EVENT OF DECREASED LEVEL OF CONSCIOUSNESS. IMDRF PATIENT CODE E0752 CAPTURES THE REPORTABLE EVENT OF RESPIRATORY ISSUES. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. 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 (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.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSGASTRIC TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) DURING A GASTROJEJUNOSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT EXPERIENCED DIFFICULTIES EXPANDING THE STENT, IT DID NOT OPEN PROPERLY. HOWEVER, THE DEVICE WAS REPORTED TO BE CURRENTLY IMPLANTED: THEREFORE, THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. IT WAS REPORTED THAT THE PATIENT DECOMPENSATED DURING THE PROCEDURE (RESPIRATORY ISSUES) AND WAS BROUGHT TO INTENSIVE CARE UNIT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) DURING A GASTROJEJUNOSTOMY PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY, AND THE BILE DUCT AFTER FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED TO BE IMPLANTED BETWEEN THE STOMACH AND THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO).
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSGASTRIC TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) DURING A GASTROJEJUNOSTOMY PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT EXPERIENCED DIFFICULTIES EXPANDING THE STENT, IT DID NOT OPEN PROPERLY. HOWEVER, THE DEVICE WAS REPORTED TO BE CURRENTLY IMPLANTED: THEREFORE, THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. IT WAS REPORTED THAT THE PATIENT DECOMPENSATED DURING THE PROCEDURE (RESPIRATORY ISSUES) AND WAS BROUGHT TO INTENSIVE CARE UNIT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE IMPLANTED TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) DURING A GASTROJEJUNOSTOMY PROCEDURE. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF A PANCREATIC PSEUDOCYST OR A WALLED-OFF NECROSIS WITH AT LEAST 70 PERCENT OF FLUID CONTENT, GALLBLADDER IN PATIENTS WITH ACUTE CHOLECYSTITIS WHO ARE AT HIGH RISK OR UNSUITABLE FOR SURGERY, AND THE BILE DUCT AFTER FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN PATIENTS WITH BILIARY OBSTRUCTION DUE TO A MALIGNANT STRICTURE. THE DEVICE IS NOT INDICATED TO BE IMPLANTED BETWEEN THE STOMACH AND THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2809618 | AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553560 | 0037461035 | 08714729951100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |