Axios Stent and Delivery System
Received Jun 25, 2026 · Event occurred May 28, 2026
Report 3005099803-2026-02586 · MDR key 25630305
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
UNK-P-Cold_AxiosCatalog number
UNK-P-Cold_Axios
Product problems
- Entrapment of Device
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF STENT SECOND FLANGE STUCK IN SCOPE. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. WE'VE SENT GOOD FAITH EFFORT ATTEMPTS TO OBTAIN ALL MISSING INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSGASTRIC TO TREAT A PSEUDOCYST DURING A DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE SECOND FLANGE DID NOT DEPLOY OUT OF THE SCOPE. THE PHYSICIAN TRIED TO PLUNGE AND TORQUE SCOPE TO THE RIGHT BUT WAS UNSUCCESSFULLY. THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY USING ANOTHER AXIOS STENT THROUGH THE INITIAL PUNCTURE SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.