AXIOS
Report
- Report Number
- 3005099803-2025-00202
- Event Type
- Injury
- Date Received
- January 29, 2025
- Date of Event
- November 26, 2024
- Report Date
- May 7, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729951179
- PMA / PMN Number
- K233318
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 11, 2025. BLOCK D2B: PRO CODE (PRODUCT CODE): PCU; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K181905, K220112, K233318; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: E7127 PASSAGE CLINICAL STUDY. BLOCK H6: IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF DECREASED BOWEL PERISTALSIS. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION. PERFORMED TO ADDRESS THE PATIENT COMPLICATION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED.
BLOCKS A1, G4 (PREMARKET/510(K)) AND H11 WERE CORRECTED. BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON APRIL 11, 2025. BLOCK H6: IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF DECREASED BOWEL PERISTALSIS. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION PERFORMED TO ADDRESS THE PATIENT COMPLICATION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED.
BLOCK D2B: PRO CODE (PRODUCT CODE): PCU; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K181905, K220112, K233318; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: (B)(6) PASSAGE CLINICAL STUDY. BLOCK H6: IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF DECREASED BOWEL PERISTALSIS. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION PERFORMED TO ADDRESS THE PATIENT COMPLICATION. IMDRF IMPACT CODE F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSDUODENAL TO THE PYLORUS TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) DURING A PROCEDURE PERFORMED ON (B)(6) 2024, AS PART OF THE E7127 PASSAGE CLINICAL TRIAL. THE PATIENT WAS ENROLLED INTO THE CLINICAL TRIAL ON (B)(6) 2024. THE STENT WAS IMPLANTED SUCCESSFULLY. POST- DILATION WAS NOT PERFORMED, AND STENT PATENCY COULD BE VISUALIZED. ON (B)(6) 2024, 21-DAY POST INDEX PROCEDURE, THE PATIENT EXPERIENCED DECREASED BOWEL PERISTALSIS. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED WHICH REVEALED A SLIGHTLY ENLARGED MASSES OF THE HEAD OF PANCREAS, DILATED DUODENUM AND STOMACH ALONG WITH OBSTRUCTION OF THE PASSAGE, PNEUMOBILIA AND HEPATIC STEATOSIS. A LARGE AMOUNT OF GASTRIC CONTENTS WAS ALSO RETAINED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A NASOGASTRIC TUBE WAS PLACED TO TREAT THE EVENT. ON (B)(6) 2024, UPPER ULTRASOUND ENDOSCOPY WAS PERFORMED WHICH REVEALED THAT THE STOMACH CONTENTS WERE DRAINED OUT FROM THE GASTRIC TUBE AND THE AXIOS STENT DID NOT SHOW ANY SIGNS OF OBSTRUCTION IN THE PASSAGE. ON (B)(6) 2024, LIQUID DIET WAS STARTED ALONG WITH MEDICATION. ON (B)(6) 2024, THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 11, 2025. IT WAS REPORTED THAT THE PATIENT COMPLICATION REPORTED OF DECREASE BOWEL PERISTALSIS IS NOT RELATED TO THE DEVICE. ADDITIONALLY, THE REPORTED PNEUMOBILIA AND HEPATIC STEATOSIS WERE NOT CONSIDERED AN ADVERSE EVENT OF THE DEVICE SINCE THESE SYMPTOMS WERE PRESENT PRIOR TO THE PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSDUODENAL TO THE PYLORUS TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) DURING A PROCEDURE PERFORMED ON (B)(6) 2024, AS PART OF A CLINICAL TRIAL. THE PATIENT WAS ENROLLED INTO THE CLINICAL TRIAL ON (B)(6) 2024. THE STENT WAS IMPLANTED SUCCESSFULLY. POST- DILATION WAS NOT PERFORMED, AND STENT PATENCY COULD BE VISUALIZED. ON (B)(6) 2024, 21-DAY POST INDEX PROCEDURE, THE PATIENT EXPERIENCED DECREASED BOWEL PERISTALSIS. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED WHICH REVEALED A SLIGHTLY ENLARGED MASSES OF THE HEAD OF PANCREAS, DILATED DUODENUM AND STOMACH ALONG WITH OBSTRUCTION OF THE PASSAGE, PNEUMOBILIA AND HEPATIC STEATOSIS. A LARGE AMOUNT OF GASTRIC CONTENTS WAS ALSO RETAINED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A NASOGASTRIC TUBE WAS PLACED TO TREAT THE EVENT. ON (B)(6) 2024, UPPER ULTRASOUND ENDOSCOPY WAS PERFORMED WHICH REVEALED THAT THE STOMACH CONTENTS WERE DRAINED OUT FROM THE GASTRIC TUBE AND THE AXIOS STENT DID NOT SHOW ANY SIGNS OF OBSTRUCTION IN THE PASSAGE. ON (B)(6) 2024, LIQUID DIET WAS STARTED ALONG WITH MEDICATION. ON (B)(6) 2024, THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. ***ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 11, 2025*** IT WAS REPORTED THAT THE PATIENT COMPLICATION REPORTED OF DECREASE BOWEL PERISTALSIS IS NOT RELATED TO THE DEVICE. ADDITIONALLY, THE REPORTED PNEUMOBILIA AND HEPATIC STEATOSIS WERE NOT CONSIDERED AN ADVERSE EVENT OF THE DEVICE SINCE THESE SYMPTOMS WERE PRESENT PRIOR TO THE PROCEDURE. ***ADDITIONAL INFORMATION RECEIVED ON APRIL 11, 2025*** IT WAS REPORTED THAT THE PATIENT COMPLICATION REPORTED OF DECREASE BOWEL PERISTALSIS IS RELATED TO THE DEVICE OR INDEX PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSDUODENAL TO THE PYLORUS TO TREAT A GASTRIC OUTLET OBSTRUCTION (GOO) DURING A PROCEDURE PERFORMED ON (B)(6) 2024, AS PART OF THE (B)(6) PASSAGE CLINICAL TRIAL. THE PATIENT WAS ENROLLED INTO THE CLINICAL TRIAL ON (B)(6) 2024. THE STENT WAS IMPLANTED SUCCESSFULLY. POST- DILATION WAS NOT PERFORMED, AND STENT PATENCY COULD BE VISUALIZED. ON (B)(6) 2024, 21-DAY POST INDEX PROCEDURE, THE PATIENT EXPERIENCED DECREASED BOWEL PERISTALSIS. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED WHICH REVEALED A SLIGHTLY ENLARGED MASSES OF THE HEAD OF PANCREAS, DILATED DUODENUM AND STOMACH ALONG WITH OBSTRUCTION OF THE PASSAGE, PNEUMOBILIA AND HEPATIC STEATOSIS. A LARGE AMOUNT OF GASTRIC CONTENTS WAS ALSO RETAINED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A NASOGASTRIC TUBE WAS PLACED TO TREAT THE EVENT. ON (B)(6) 2024, UPPER ULTRASOUND ENDOSCOPY WAS PERFORMED WHICH REVEALED THAT THE STOMACH CONTENTS WERE DRAINED OUT FROM THE GASTRIC TUBE AND THE AXIOS STENT DID NOT SHOW ANY SIGNS OF OBSTRUCTION IN THE PASSAGE. ON (B)(6) 2024, LIQUID DIET WAS STARTED ALONG WITH MEDICATION. ON (B)(6) 2024, THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 830989 | AXIOS | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553660 | 0034172979 | 08714729951179 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Hospitalization| R |