AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Apr 16, 2026 · Event occurred Mar 23, 2026
Report 3005099803-2026-01398 · MDR key 24901360
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553570Catalog number
M00553570
Lot number
0038330118
Product problems
- Entrapment of Device
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK E1: INITIAL REPORTER CITY: (B)(6); REPORTED HERE AS THE CITY EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A150208 CAPTURES THE REPORTABLE EVENT OF 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 TRANSGASTRIC TO THE PANCREAS TO TREAT A PANCREATIC PSEUDOCYST DURING A DRAINAGE 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 SECOND FLANGE DID NOT RELEASE FROM THE SCOPE. THE DEVICE AND ENDOSCOPE WERE REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.