Axios?
Received Jun 29, 2026 · Event occurred May 21, 2026
Report 3005099803-2026-02607 · MDR key 25659546
Device
Generic name
Pancreatic Stent, Covered, Metallic, Removable
Manufacturer
Boston Scientific CorporationModel number
M00553650Catalog number
M00553650
Lot number
0038640618
Product problems
- Activation, Positioning or Separation Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED.
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 IN THE PANCREAS TO TREAT A PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PROXIMAL FLANGE WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, IT DID NOT DEPLOY AND REMAINED WITHIN THE SHEATH. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.