AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Jul 14, 2026 · Event occurred Jun 17, 2026
Report 3005099803-2026-02809 · MDR key 25815510
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553550Catalog number
M00553550
Lot number
0037291151
Product problems
- Positioning Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY.
Description of Event or Problem
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED TRANSGATRIC TO THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, DEPLOYMENT OF THE FIRST FLANGE OF THE STENT WAS ATTEMPTED; HOWEVER, THE FLANGE DID NOT OPEN. THE CATHETER WAS MANIPULATED BY ADVANCING AND WITHDRAWING IT IN AN EFFORT TO FACILITATE DEPLOYMENT, BUT NO RESPONSE WAS OBSERVED. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE OKAY.