AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Apr 13, 2026 · Event occurred Mar 23, 2026
Report 3005099803-2026-01343 · MDR key 24867057
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553560Catalog number
M00553560
Lot number
0036856185
Product problems
- Positioning Failure
- Adverse Event Without Identified Device or Use Problem
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 INTENDED TO BE IMPLANTED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. IT WAS REPORTED THAT THE DEVICE FAILED DUE TO A DEPLOYMENT MALFUNCTION, AS DIFFICULTIES WERE ENCOUNTERED DURING BOTH DEPLOYMENT AND EXPANSION. THE PROCEDURE WAS COMPLETED BY REPLACING AND USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AT THIS TIME.