AXIOS?
Report
- Report Number
- 3005099803-2025-05392
- Event Type
- Death
- Date Received
- October 15, 2025
- Date of Event
- September 1, 2025
- Report Date
- January 13, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729951179
- PMA / PMN Number
- K233318
- Removal / Correction Number
- 3005099803-12192025-004-
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE EVENT OF ABSCESS. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF PATIENT CODE E0505 CAPTURES THE REPORTABLE EVENT OF HEMATOMA. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF INFECTION. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION.
BLOCK H6: IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND.
BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E172001 CAPTURES THE REPORTABLE EVENT OF ABSCESS. IMDRF PATIENT CODE E0306 CAPTURES THE REPORTABLE EVENT OF SEPSIS. IMDRF PATIENT CODE E0505 CAPTURES THE REPORTABLE EVENT OF HEMATOMA. IMDRF PATIENT CODE E1906 CAPTURES THE REPORTABLE EVENT OF INFECTION. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION. BLOCK H7 AND H9: ADDED TYPE OF REMEDIAL ACTION AND THE CORRECTION/REMOVAL REPORTING # INFORMATION. BLOCK H11: AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS, IT WAS RETURNED WITH THE STENT PARTIALLY DEPLOYED. THE DEVICE ANALYSIS CONFIRMED THE REPORTED EVENTS OF STENT FIRST FLANGE FAILURE TO EXPAND AND DEVICE USE ISSUE. THE DEVICE WAS RETURNED WITH THE STENT PARTIALLY DEPLOYED, WHICH IS NOTED IN THE INSTRUCTIONS FOR USE (IFU) AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH DEVICE USE. UPON INSPECTION, THE CATHETER WAS FOUND UNLOCKED, WITH THE LOCK MOVED TO THE RIGHT. THE CATHETER CONTROL HUB HAD BEEN MOVED UP AND DOWN, AND THE CATHETER PASSED THROUGH THE LUER WITH HIGH RESISTANCE. THE STENT HUB WAS THEN MOVED FROM THE SECOND TO THE FOURTH POSITION, AND THE STENT WAS DEPLOYED, PRESENTING A SLOW EXPANSION ISSUE. EVENTUALLY, THE STENT EXPANDED; HOWEVER, A KINK WAS OBSERVED ON THE INNER SHEATH. A FUNCTIONAL TEST WAS PERFORMED: THE DELIVERY SYSTEM WAS LOADED ONTO A GUIDEWIRE BUT DID NOT EXIT AT THE NOSE CONE. IT WAS INTRODUCED THROUGH THE SIDE OF THE NOSE CONE AND STOPPED AT 7.5 CM. THE GUIDEWIRE COULD NOT PASS THROUGH DUE TO THE KINK IN THE INNER SHEATH, LOCATED AT THE SAME POINT WHERE THE GUIDEWIRE BECAME STUCK. THE REPORTED DIFFICULTIES WERE MOST LIKELY DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, DEVICE HANDLING, OR TECHNIQUE, WHICH COULD HAVE RESULTED IN DAMAGE TO THE INNER SHEATH. REGARDING THE ADDITIONAL OBSERVATION OF STENT SLOW EXPANSION, THE STENT IS DESIGNED TO PERFORM IN A CLINICALLY RELEVANT MANNER THROUGHOUT ITS SHELF LIFE. IN A PROCEDURAL SETTING, FACTORS SUCH AS ANATOMY, COMPRESSION, TIME, TEMPERATURE, AND HUMIDITY CAN INFLUENCE EXPANSION RATES. THE REPORTED IMAGING REQUIRED WAS CLASSIFIED AS AN ADVERSE EVENT RELATED TO PROCEDURE, AS BLEEDING OCCURRED IMMEDIATELY AFTER THE INTERVENTION AND WAS CONFIRMED THROUGH IMAGING. THE CLINICAL OBSERVATION OF ABSCESS COULD NOT BE CONFIRMED, AS THERE WAS NO OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS TO ESTABLISH ITS CAUSE. ADDITIONALLY, THE REPORTED EVENTS OF STENT PARTIALLY DEPLOYED, PERFORATION, SEPSIS, INFECTION, HEMORRHAGE (MAJOR), HEMATOMA, SURGICAL INTERVENTION, AND DEATH ARE NOTED IN THE IFU AS POSSIBLE ADVERSE EVENTS ASSOCIATED WITH DEVICE USE. CONCLUSION: BASED ON ALL AVAILABLE INFORMATION, THE OVERALL ROOT CAUSE OF THE REPORTED EVENTS IS CLASSIFIED AS A KNOWN INHERENT RISK OF DEVICE. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE INSTRUCTIONS FOR USE/PRODUCT LABEL, AS IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT PYLORIC STENOSIS DURING AN EDGE PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANS GASTRIC 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 TREAT PYLORIC STENOSIS DURING AN EDGE PROCEDURE, CONFIRMING THE OFF-LABEL USE. ADDITIONALLY, STENT PARTIALLY DEPLOYED, PERFORATION, SEPSIS, INFECTION, HEMORRHAGE, MAJOR, HEMATOMA, SURGICAL INTERVENTION AND DEATH ARE NOTED WITHIN THE IFU AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. 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 INTENDED TO BE IMPLANTED TO TREAT A BILIARY SEPSIS DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANS GASTRIC ERCP (EDGE) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL FLANGE FAILED TO DEPLOY DESPITE A SUCCESSFUL CAUTERY-ASSISTED PUNCTURE. ALTHOUGH THE HANDLE REACHED THE EXPECTED POSITION, THE STENT DID NOT RELEASE. SEVERAL MANEUVERS WERE ATTEMPTED OVER APPROXIMATELY 10 MINUTES, INCLUDING ADJUSTING SCOPE POSITION AND PERFORMING TO-AND-FRO MOVEMENTS, BUT NONE WERE SUCCESSFUL. A GUIDEWIRE WAS INTRODUCED, THOUGH IT COULD NOT PASS THROUGH THE DISTAL END OF THE DELIVERY SYSTEM. THERE DID NOT APPEAR TO BE MUCH RETRACTION OF THE OUTER SHEATH UPON REMOVAL. A SECOND STENT WAS THEN SUCCESSFULLY PLACED ADJACENT TO THE INITIAL PUNCTURE SITE. ERCP WAS NOT PERFORMED DURING THIS PROCEDURE. HOWEVER, AFTER DEPLOYMENT OF THE SECOND STENT, BLOOD WAS OBSERVED BETWEEN THE GASTRIC POUCH AND THE EXCLUDED STOMACH, APPEARING AS HYPERECHOIC FLUID ON ENDOSONOGRAPHY. POST-PROCEDURE, THE PATIENT SHOWED SIGNS OF ACTIVE BLEEDING, WHICH REQUIRED IR EMBOLIZATION FOR CONTROL. SUBSEQUENTLY, THE PATIENT DEVELOPED WORSENING SEPSIS OF UNCLEAR ORIGIN, BILIARY SEPSIS OR AN INFECTED HEMATOMA WERE CONSIDERED. AS THE CLINICAL CONDITION DETERIORATED, CARE WAS WITHDRAWN. IT WAS REPORTED THAT THE PATIENT PASSED AWAY APPROXIMATELY 48 HOURS AFTER THE PROCEDURE; HOWEVER, THE CAUSE OF DEATH REMAINS UNKNOWN AT THIS TIME. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT PYLORIC STENOSIS DURING AN EDGE PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANS GASTRIC 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 TREAT PYLORIC STENOSIS DURING AN EDGE PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL FLANGE FAILED TO DEPLOY. IT WAS REPORTED THAT THE PATIENT PASSED AWAY; HOWEVER, THE CAUSE OF DEATH REMAINS UNKNOWN AT THIS TIME.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO TREAT A BILIARY SEPSIS DURING AN ENDOSCOPIC ULTRASOUND (EUS)-DIRECTED TRANS GASTRIC ERCP (EDGE) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DISTAL FLANGE FAILED TO DEPLOY DESPITE A SUCCESSFUL CAUTERY-ASSISTED PUNCTURE. ALTHOUGH THE HANDLE REACHED THE EXPECTED POSITION, THE STENT DID NOT RELEASE. SEVERAL MANEUVERS WERE ATTEMPTED OVER APPROXIMATELY 10 MINUTES, INCLUDING ADJUSTING SCOPE POSITION AND PERFORMING TO-AND-FRO MOVEMENTS, BUT NONE WERE SUCCESSFUL. A GUIDEWIRE WAS INTRODUCED, THOUGH IT COULD NOT PASS THROUGH THE DISTAL END OF THE DELIVERY SYSTEM. THERE DID NOT APPEAR TO BE MUCH RETRACTION OF THE OUTER SHEATH UPON REMOVAL. A SECOND STENT WAS THEN SUCCESSFULLY PLACED ADJACENT TO THE INITIAL PUNCTURE SITE. ERCP WAS NOT PERFORMED DURING THIS PROCEDURE. HOWEVER, AFTER DEPLOYMENT OF THE SECOND STENT, BLOOD WAS OBSERVED BETWEEN THE GASTRIC POUCH AND THE EXCLUDED STOMACH, APPEARING AS HYPERECHOIC FLUID ON ENDOSONOGRAPHY. POST-PROCEDURE, THE PATIENT SHOWED SIGNS OF ACTIVE BLEEDING, WHICH REQUIRED IR EMBOLIZATION FOR CONTROL. SUBSEQUENTLY, THE PATIENT DEVELOPED WORSENING SEPSIS OF UNCLEAR ORIGIN, BILIARY SEPSIS OR AN INFECTED HEMATOMA WERE CONSIDERED. AS THE CLINICAL CONDITION DETERIORATED, CARE WAS WITHDRAWN. IT WAS REPORTED THAT THE PATIENT PASSED AWAY APPROXIMATELY 48 HOURS AFTER THE PROCEDURE; HOWEVER, THE CAUSE OF DEATH REMAINS UNKNOWN AT THIS TIME. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT PYLORIC STENOSIS DURING AN EDGE PROCEDURE. HOWEVER, ACCORDING TO THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANS GASTRIC 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 TREAT PYLORIC STENOSIS DURING AN EDGE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2358804 | AXIOS? | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553660 | 0036990382 | 08714729951179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |