AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Jul 15, 2026 · Event occurred Jun 25, 2026
Report 3005099803-2026-02839 · MDR key 25830663
Device
Generic name
Gallbladder Drainage Stent And Delivery System
Manufacturer
Boston Scientific CorporationModel number
M00553540Catalog number
M00553540
Lot number
0039114043
Product problems
- Positioning Failure
- Mechanical Jam
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A0506 CAPTURES THE REPORTABLE EVENT OF STENT LOCK FAILURE TO UNLOCK. 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 TRANSDUODENAL TO THE GALLBLADDER DURING AN ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED DUE TO LOCK MECHANISM PROBLEM. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH, AND THE PROCEDURE WAS COMPLETED USING ANOTHER AXIOS STENT. THERE WAS NO PATIENT INJURY REPORTED DUE TO THIS EVENT.