AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Jan 6, 2026 · Event occurred Sep 29, 2025
Report 3005099803-2026-00062 · MDR key 23983536
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553560Catalog number
M00553560
Lot number
0035691975
Product problems
- Positioning Failure
Patient
59 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
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 DURING AN ENDOSCOPIC PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE AXIOS STENT DISTAL FLANGE DID NOT DEPLOY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A150201 CAPTURES THE REPORTABLE EVENT OF STENT FAILURE TO DEPLOY.