AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Report
- Report Number
- 3005099803-2025-06562
- Event Type
- Death
- 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
- 3005099803-12192025-004-
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF PATIENT CODE E0717 CAPTURES THE REPORTABLE EVENT OF DYSPNEA. IMDRF PATIENT CODE E060102 CAPTURES THE REPORTABLE EVENT OF ATRIAL FIBRILATION. IMDRF PATIENT CODE E060110 CAPTURES THE REPORTABLE EVENT OF VENTRICULAR FIBRILATION. IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF HYPOTENSION. IMDRF PATIENT CODE E0704 CAPTURES THE REPORTABLE EVENT OF ASPIRATION. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E0726 CAPTURES THE REPORTABLE EVENT OF HYPOXIA. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E060109 CAPTURES THE REPORTABLE EVENT OF TACHYCARDIA. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. 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.
BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF PATIENT CODE E0717 CAPTURES THE REPORTABLE EVENT OF DYSPNEA. IMDRF PATIENT CODE E060102 CAPTURES THE REPORTABLE EVENT OF ATRIAL FIBRILATION. IMDRF PATIENT CODE E060110 CAPTURES THE REPORTABLE EVENT OF VENTRICULAR FIBRILATION. IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF HYPOTENSION. IMDRF PATIENT CODE E0704 CAPTURES THE REPORTABLE EVENT OF ASPIRATION. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E0726 CAPTURES THE REPORTABLE EVENT OF HYPOXIA. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E060109 CAPTURES THE REPORTABLE EVENT OF TACHYCARDIA. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.
BLOCK B5: UPDATED EVENT DESCRIPTION. BLOCK H6: IMDRF DEVICE CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILURE TO EXPAND. IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION. IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF PATIENT CODE E0717 CAPTURES THE REPORTABLE EVENT OF DYSPNEA. IMDRF PATIENT CODE E060102 CAPTURES THE REPORTABLE EVENT OF ATRIAL FIBRILATION. IMDRF PATIENT CODE E060110 CAPTURES THE REPORTABLE EVENT OF VENTRICULAR FIBRILATION. IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF HYPOTENSION. IMDRF PATIENT CODE E0704 CAPTURES THE REPORTABLE EVENT OF ASPIRATION. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E0726 CAPTURES THE REPORTABLE EVENT OF HYPOXIA. IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E060109 CAPTURES THE REPORTABLE EVENT OF TACHYCARDIA. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED BETWEEN THE STOMACH AND THE DUODENUM IN AN 81-YEAR-OLD FEMALE PATIENT WITH TERMINAL CANCER, DIAGNOSED WITH BOTH PANCREATIC CANCER AND RENAL CELL CARCINOMA, PRESENTING WITH 72 HOURS OF GASTRIC OUTLET OBSTRUCTION (GOO) SYMPTOMS, DURING A PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT STATED THAT THEY WERE ONLY INTERESTED IN PALLIATIVE CARE. DURING THE PROCEDURE, INITIAL PUNCTURE FROM THE STOMACH INTO THE DUODENUM WAS SUCCESSFUL, WITH FAVORABLE ANATOMY AND ADEQUATE SPACE FOR DELIVERY SYSTEM CATHETER ADVANCEMENT. UNDER PROPOFOL ANESTHESIA, SEVERE HYPOXIA DEVELOPED (OXYGEN SATURATION 60%). THE PHYSICIAN WAS ADVISED TO ABORT THE PROCEDURE DUE TO HYPOXIA BUT PROCEEDED WITH RAPID DEPLOYMENT OF THE AXIOS STENT TO AVOID LEAVING A JEJUNAL PERFORATION. THE DISTAL FLANGE OPENED SLOWLY AND ONLY PARTIALLY (IT WASN'T OPENING) DESPITE REPOSITIONING MANEUVERS, WHILE THE PATIENT WAS DESATURATING AT THE SAME TIME. THE PROXIMAL FLANGE WAS DEPLOYED QUICKLY AND SUCCESSFULLY. BLUE FLUID WAS OBSERVED ENTERING THE STOMACH AND THE SCOPE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS POSITIONED SUPINE, AND RESUSCITATION WAS PERFORMED WITH 100% OXYGEN VIA NON-REBREATHER MASK, TILL THE PATIENT WENT BACK UP TO 95%; UNFORTUNATELY, DUE TO THIS EVENT, THE PHYSICIAN COULD NOT REINSERT THE SCOPE TO CHECK STENT PLACEMENT. IN RECOVERY, PERSISTENT DYSPNEA, ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE, AND HYPOTENSION WERE NOTED AS WELL AS ELEVATED HEART RATE (HR) AND WAS COMPLAINING ABOUT DIFFICULTY BREATHING AND MILD ABDOMINAL PAIN. THEREFORE, AN X-RAY WERE ORDERED AND ONCE THE PATIENT WAS SABLE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED WHICH CONFIRMED STENT MISDEPLOYEMENT OF THE DISTAL FLANGE, WHERE THE DISTAL FLANGE WAS IN THE PERITONEUM AND PROXIMAL FLANGE IN THE STOMACH. TREATMENT INCLUDED INTRAVENOUS ANTIBIOTICS, RATE-CONTROL MEDICATION, AND VASOPRESSORS (PHENYLEPHRINE AND NOREPINEPHRINE). AFTER APPROXIMATELY FOUR HOURS, HYPOXIA IMPROVED TO THE POINT WHERE OXYGEN WAS ONLY REQUIRED BY NASAL CANNULA OXYGEN, AND ARRHYTHMIA WAS BETTER CONTROLLED, THOUGH HYPOTENSION PERSISTED. THE PATIENT'S OXYGEN SATURATION INCREASED TO 87% AND HE WAS AWAKE AT THE TIME OF TRANSFER TO THE PACU FOR AN ICU CONSULTATION. ADDITIONALLY, A COMPUTED TOMOGRAPHY (CT) REVEALED INTRAPERITONEAL FLUID AND GAS, WITH APPARENT DISCONNECTION OF THE DISTAL FLANGE FROM THE JEJUNUM. AT THAT POINT, THE PATIENT AND FAMILY AGREED TO KEEP THE PATIENT COMFORTABLE, AND NO FURTHER INTERVENTIONS WOULD BE PERFORMED TO CORRECT THE PERFORATION. IT WAS NOTED THAT ASPIRATION DURING THE PROCEDURE WAS IDENTIFIED AS THE INITIAL EVENT LEADING TO HYPOXIA. IT WAS REPORTED THAT THE PATIENT PASSED AWAY THE DAY AFTER THE PROCEDURE, ON (B)(6) 2025.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED BETWEEN THE STOMACH AND THE DUODENUM IN AN 81-YEAR-OLD FEMALE PATIENT WITH TERMINAL CANCER, DIAGNOSED WITH BOTH PANCREATIC CANCER AND RENAL CELL CARCINOMA, PRESENTING WITH 72 HOURS OF GASTRIC OUTLET OBSTRUCTION (GOO) SYMPTOMS, DURING A PROCEDURE PERFORMED ON (B)(6), 2025. THE PATIENT STATED THAT THEY WERE ONLY INTERESTED IN PALLIATIVE CARE. DURING THE PROCEDURE, INITIAL PUNCTURE FROM THE STOMACH INTO THE DUODENUM WAS SUCCESSFUL, WITH FAVORABLE ANATOMY AND ADEQUATE SPACE FOR DELIVERY SYSTEM CATHETER ADVANCEMENT. UNDER PROPOFOL ANESTHESIA, SEVERE HYPOXIA DEVELOPED (OXYGEN SATURATION 60%). THE PHYSICIAN WAS ADVISED TO ABORT THE PROCEDURE DUE TO HYPOXIA BUT PROCEEDED WITH RAPID DEPLOYMENT OF THE AXIOS STENT TO AVOID LEAVING A JEJUNAL PERFORATION. THE DISTAL FLANGE OPENED SLOWLY AND ONLY PARTIALLY (IT WASN'T OPENING) DESPITE REPOSITIONING MANEUVERS, WHILE THE PATIENT WAS DESATURATING AT THE SAME TIME. THE PROXIMAL FLANGE WAS DEPLOYED QUICKLY AND SUCCESSFULLY. BLUE FLUID WAS OBSERVED ENTERING THE STOMACH AND THE SCOPE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS POSITIONED SUPINE, AND RESUSCITATION WAS PERFORMED WITH 100% OXYGEN VIA NON-REBREATHER MASK, TILL THE PATIENT WENT BACK UP TO 95%; UNFORTUNATELY, DUE TO THIS EVENT, THE PHYSICIAN COULD NOT REINSERT THE SCOPE TO CHECK STENT PLACEMENT. IN RECOVERY, PERSISTENT DYSPNEA, ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE, AND HYPOTENSION WERE NOTED AS WELL AS ELEVATED HEART RATE (HR) AND WAS COMPLAINING ABOUT DIFFICULTY BREATHING AND MILD ABDOMINAL PAIN. THEREFORE, AN X-RAY WERE ORDERED AND ONCE THE PATIENT WAS SABLE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED WHICH CONFIRMED STENT MISDEPLOYEMENT OF THE DISTAL FLANGE. TREATMENT INCLUDED INTRAVENOUS ANTIBIOTICS, RATE-CONTROL MEDICATION, AND VASOPRESSORS (PHENYLEPHRINE AND NOREPINEPHRINE). AFTER APPROXIMATELY FOUR HOURS, HYPOXIA IMPROVED TO THE POINT WHERE OXYGEN WAS ONLY REQUIRED BY NASAL CANNULA OXYGEN, AND ARRHYTHMIA WAS BETTER CONTROLLED, THOUGH HYPOTENSION PERSISTED. THE PATIENT'S OXYGEN SATURATION INCREASED TO 87% AND HE WAS AWAKE AT THE TIME OF TRANSFER TO THE PACU FOR AN ICU CONSULTATION. ADDITIONALLY, A COMPUTED TOMOGRAPHY (CT) REVEALED INTRAPERITONEAL FLUID AND GAS, WITH APPARENT DISCONNECTION OF THE DISTAL FLANGE FROM THE JEJUNUM. AT THAT POINT, THE PATIENT AND FAMILY AGREED TO KEEP THE PATIENT COMFORTABLE, AND NO FURTHER INTERVENTIONS WOULD BE PERFORMED TO CORRECT THE PERFORATION. IT WAS NOTED THAT ASPIRATION DURING THE PROCEDURE WAS IDENTIFIED AS THE INITIAL EVENT LEADING TO HYPOXIA. IT WAS REPORTED THAT THE PATIENT PASSED AWAY THE DAY AFTER THE PROCEDURE, ON (B)(6) 2025.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED BETWEEN THE STOMACH AND THE DUODENUM IN AN 81-YEAR-OLD FEMALE PATIENT WITH TERMINAL CANCER, DIAGNOSED WITH BOTH PANCREATIC CANCER AND RENAL CELL CARCINOMA, PRESENTING WITH 72 HOURS OF GASTRIC OUTLET OBSTRUCTION (GOO) SYMPTOMS, DURING A PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT STATED THAT THEY WERE ONLY INTERESTED IN PALLIATIVE CARE. DURING THE PROCEDURE, INITIAL PUNCTURE FROM THE STOMACH INTO THE DUODENUM WAS SUCCESSFUL, WITH FAVORABLE ANATOMY AND ADEQUATE SPACE FOR DELIVERY SYSTEM CATHETER ADVANCEMENT. UNDER PROPOFOL ANESTHESIA, SEVERE HYPOXIA DEVELOPED (OXYGEN SATURATION 60%). THE PHYSICIAN WAS ADVISED TO ABORT THE PROCEDURE DUE TO HYPOXIA BUT PROCEEDED WITH RAPID DEPLOYMENT OF THE AXIOS STENT TO AVOID LEAVING A JEJUNAL PERFORATION. THE DISTAL FLANGE OPENED SLOWLY AND ONLY PARTIALLY (IT WASN'T OPENING) DESPITE REPOSITIONING MANEUVERS, WHILE THE PATIENT WAS DESATURATING AT THE SAME TIME. THE PROXIMAL FLANGE WAS DEPLOYED QUICKLY AND SUCCESSFULLY. BLUE FLUID WAS OBSERVED ENTERING THE STOMACH AND THE SCOPE WAS REMOVED FROM THE PATIENT. THE PATIENT WAS POSITIONED SUPINE, AND RESUSCITATION WAS PERFORMED WITH 100% OXYGEN VIA NON-REBREATHER MASK, TILL THE PATIENT WENT BACK UP TO 95%; UNFORTUNATELY, DUE TO THIS EVENT, THE PHYSICIAN COULD NOT REINSERT THE SCOPE TO CHECK STENT PLACEMENT. IN RECOVERY, PERSISTENT DYSPNEA, ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE, AND HYPOTENSION WERE NOTED AS WELL AS ELEVATED HEART RATE (HR) AND WAS COMPLAINING ABOUT DIFFICULTY BREATHING AND MILD ABDOMINAL PAIN. THEREFORE, AN X-RAY WERE ORDERED AND ONCE THE PATIENT WAS SABLE, A COMPUTED TOMOGRAPHY (CT) SCAN WAS ORDERED WHICH CONFIRMED STENT MISDEPLOYEMENT OF THE DISTAL FLANGE, WHERE THE DISTAL FLANGE WAS IN THE PERITONEUM AND PROXIMAL FLANGE IN THE STOMACH. TREATMENT INCLUDED INTRAVENOUS ANTIBIOTICS, RATE-CONTROL MEDICATION, AND VASOPRESSORS (PHENYLEPHRINE AND NOREPINEPHRINE). AFTER APPROXIMATELY FOUR HOURS, HYPOXIA IMPROVED TO THE POINT WHERE OXYGEN WAS ONLY REQUIRED BY NASAL CANNULA OXYGEN, AND ARRHYTHMIA WAS BETTER CONTROLLED, THOUGH HYPOTENSION PERSISTED. THE PATIENT'S OXYGEN SATURATION INCREASED TO 87% AND HE WAS AWAKE AT THE TIME OF TRANSFER TO THE PACU FOR AN ICU CONSULTATION. ADDITIONALLY, A COMPUTED TOMOGRAPHY (CT) REVEALED INTRAPERITONEAL FLUID AND GAS, WITH APPARENT DISCONNECTION OF THE DISTAL FLANGE FROM THE JEJUNUM. AT THAT POINT, THE PATIENT AND FAMILY AGREED TO KEEP THE PATIENT COMFORTABLE, AND NO FURTHER INTERVENTIONS WOULD BE PERFORMED TO CORRECT THE PERFORATION. IT WAS NOTED THAT ASPIRATION DURING THE PROCEDURE WAS IDENTIFIED AS THE INITIAL EVENT LEADING TO HYPOXIA. IT WAS REPORTED THAT THE PATIENT PASSED AWAY THE DAY AFTER THE PROCEDURE, ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1899950 | 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 | 81 YR | Female | Death |