AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Jan 12, 2026 · Event occurred Dec 16, 2025
Report 3005099803-2026-00163 · MDR key 24040389
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553550Catalog number
M00553550
Lot number
0036848121
Product problems
- Difficult or Delayed Positioning
- Mechanical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A05 CAPTURES THE REPORTABLE EVENT OF STENT LOCK FAILURE TO LOCK.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRICALLY FOR CYST DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT AFTER PERFORMING STEP 4, THE STENT LOCK WAS NOT LOCKED INTO THE HANDLE, WHICH MADE IT DIFFICULT TO RELEASE THE STENT. HOWEVER, THE STENT WAS EVENTUALLY DEPLOYED IN THE CORRECT LOCATION, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.