AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
Received Jan 6, 2026 · Event occurred Dec 12, 2025
Report 3005099803-2026-00064 · MDR key 23985133
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553540Catalog number
M00553540
Lot number
0036331161
Product problems
- Use of Device Problem
- Positioning Problem
Patient
NA · Unknown
- 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 TRANSDUODENAL TO THE PANCREAS TO TREAT A WALLED-OFF NECROSIS (WON) DURING AN ENDOSCOPIC ULTRASOUND (EUS) GUIDED DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST FLANGE OF THE STENT MOVED OUT OF ITS POSITION. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. THE AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE STATE "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE."
Additional Manufacturer Narrative
BLOCK E1: THE REPORTED HEALTHCARE FACILITY IS: (B)(6). BLOCK H6: MEDICAL DEVICE PROBLEM CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE DIFFICULT TO POSITION.