AXIOS?
Report
- Report Number
- 3005099803-2025-04063
- Event Type
- Injury
- Date Received
- August 14, 2025
- Date of Event
- July 22, 2025
- Report Date
- September 29, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- 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 H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY FOR A BILIARY/GALLBLADDER INDICATION. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION REQUIRED TO ADDRESS THE PUNCTURE SITE, DUE TO THE RISK OF BILE LEAKAGE INTO THE BILE DUCT FOLLOWING THE PUNCTURE.
BLOCKS A3A (SEX) AND A3B (GENDER) WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON AUGUST 21, 2025. BLOCK G2 (REPORT SOURCE) WAS CORRECTED. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY FOR A BILIARY/GALLBLADDER INDICATION. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION REQUIRED TO ADDRESS THE PUNCTURE SITE, DUE TO THE RISK OF BILE LEAKAGE INTO THE BILE DUCT FOLLOWING THE PUNCTURE.
BLOCKS A3A (SEX) AND A3B (GENDER) WERE UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON AUGUST 21, 2025. BLOCK G2 (REPORT SOURCE) WAS CORRECTED. BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY FOR A BILIARY/GALLBLADDER INDICATION. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL INTERVENTION REQUIRED TO ADDRESS THE PUNCTURE SITE, DUE TO THE RISK OF BILE LEAKAGE INTO THE BILE DUCT FOLLOWING THE PUNCTURE. BLOCK H11: AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED UPON RECEIPT. FUNCTIONAL TESTING WAS PERFORMED. THE CATHETER WAS UNLOCKED BY SLIDING THE CATHETER LOCK TO THE RIGHT. THE CATHETER CONTROL HUB WAS THEN MOVED UP AND DOWN, AND THE CATHETER PASSED THROUGH THE LUER WITHOUT RESISTANCE. THE STENT HUB WAS SUBSEQUENTLY MOVED TO THE SECOND AND FOURTH POSITIONS, ALLOWING THE STENT TO BE DEPLOYED SUCCESSFULLY. NO OTHER DAMAGES WERE NOTED TO THE STENT AND DELIVERY SYSTEM. PRODUCT ANALYSIS UNABLE TO CONFIRM THE REPORTED ISSUE OF THE STENT FAILURE TO DEPLOY. HOWEVER, AFTER TESTING THE RETURNED DEVICE, IT WAS FOUND THAT THE STENT COULD BE DEPLOYED WITHOUT ANY PROBLEMS. THE CATHETER AND STENT MOVED AND FUNCTIONED NORMALLY DURING INSPECTION. NO DEFECTS WERE FOUND IN THE DEVICE, AND THE PRODUCT RECORDS SHOWED NO SIGNS OF A MANUFACTURING ISSUE OR RISK TO THE PATIENT. THEREFORE, THE MOST LIKELY CAUSE OF THE EVENT IS A PROCEDURE-RELATED ISSUE, NOT A PRODUCT MALFUNCTION. A LABELING REVIEW WAS PERFORMED USING WINDCHILL. THE IFU CONTAINS DETAILED DEVICE INFORMATION AND INSTRUCTIONS FOR THE DEVICE USE. ADDITIONALLY, IT WAS CONFIRMED THAT THE FOLLOWING ADVERSE EVENTS ARE ANTICIPATED IN THE IFU: STENT PARTIALLY DEPLOYED, ALSO THERE IS NO EVIDENCE THE DEVICE WAS IMPROPERLY USED PER THE IFU, AND THERE IS NO EVIDENCE THAT THERE IS ANY ISSUE WITH TRANSLATION, WORDING, OR GRAPHICS OF THE IFU/LABELING INFORMATION.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED INTO THE GALLBLADDER TO TREAT CHOLECYSTITIS DURING A GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THAT THE STENT INNER FLANGE WAS NOT ABLE TO BE DEPLOYED AT ALL. ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE 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 INTO THE GALLBLADDER TO TREAT CHOLECYSTITIS DURING A GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THAT THE STENT INNER FLANGE WAS NOT ABLE TO BE DEPLOYED AT ALL. ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE 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 INTO THE GALLBLADDER TO TREAT CHOLECYSTITIS DURING A GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THAT THE STENT INNER FLANGE WAS NOT ABLE TO BE DEPLOYED AT ALL. ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2687713 | AXIOS? | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553640 | 0035993614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |