AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Jul 9, 2026 · Event occurred Jun 17, 2026
Report 3005099803-2026-02736 · MDR key 25767045
Device
Generic name
Gallbladder Drainage Stent And Delivery System
Manufacturer
Boston Scientific CorporationModel number
M00553540Catalog number
M00553540
Lot number
0038991195
Product problems
- Entrapment of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF STENT SECOND FLANGE STUCK IN SCOPE.
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 GALLBLADDER DURING A CHOLECYSTODUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2026. THE PHYSICIAN WAS USING THE EUS METHOD OF DEPLOYMENT WHERE THE SECOND FLANGE OF THE STENT IS DEPLOYED IN THE SCOPE, AND THEN THE STENT IS RELEASED FROM THE SCOPE BY ADVANCING THE CATHETER AND RETRACTING THE SCOPE IN A 1:1 FASHION. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED; HOWEVER, IT WAS NOT POSSIBLE TO PUSH THE STENT OUT OF THE WORKING CHANNEL. THE STENT WAS REMOVED TOGETHER WITH THE SCOPE, AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.