AXIOS
Report
- Report Number
- 3005099803-2025-00511
- Event Type
- Malfunction
- Date Received
- February 19, 2025
- Date of Event
- January 23, 2025
- Report Date
- March 27, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- UDI-DI
- 08714729904595
- PMA / PMN Number
- K233318
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: PRO CODE (PRODUCT CODE): PCU, QXH; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K)#: DEN230019, K150692, K153088, K181905, K220112, K233318; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED.
BLOCK D2B: PRO CODE (PRODUCT CODE): PCU, QXH; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K)#: DEN230019, K150692, K153088, K181905, K220112; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED. BLOCK H11: AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT FULLY COVERED AND UNDEPLOYED. THE DEPLOYMENT HUB WAS RETURNED DETACHED AND SEPARATED. NO OTHER ISSUES WERE FOUND WITH THE STENT OR THE DELIVERY SYSTEM. THE REPORTED EVENT OF STENT PARTIALLY DEPLOYED WAS NOT CONFIRMED AS THE DEVICE WAS RETURNED FULLY COVERED AND UNDEPLOYED. HOWEVER, STENT PARTIALLY DEPLOYED IS NOTED WITHIN THE PRODUCT LABELING AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE. THE INVESTIGATION CONCLUDED THAT THE ADDITIONAL REPORTED EVENT OF HANDLE BREAK WAS LIKELY DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE AND THE TECHNIQUE USED BY THE PHYSICIAN (EXCESSIVE FORCE APPLIED), THAT COULD HAVE RESULTED IN THIS DAMAGE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE OF THE REPORTED EVENTS IS KNOWN INHERENT RISK OF DEVICE. A PRODUCT LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS USED PER THE INSTRUCTIONS FOR USE (IFU)/PRODUCT LABEL. STENT PARTIALLY DEPLOYED IS NOTED WITHIN THE PRODUCT LABELING AS A POSSIBLE ADVERSE EVENT ASSOCIATED WITH THE USE OF THE DEVICE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGASTRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FISTULA FORMATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, DURING THE FINAL STEP OF DEPLOYMENT, THE STENT DEPLOYMENT HUB WAS DAMAGED, AND THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. NO PATIENT COMPLICATIONS WERE 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 TRANSGASTRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND-GUIDED FISTULA FORMATION PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, DURING THE FINAL STEP OF DEPLOYMENT, THE STENT DEPLOYMENT HUB WAS DAMAGED, AND THE STENT COULD NOT BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2538873 | AXIOS | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00553650 | 0032986911 | 08714729904595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |