AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF IMPACT CODE F1901 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL SURGERY. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF INTENSIVE CARE. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF HEMORRHAGE/BLOODLOSS/BLEEDING. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF LOW BLOOD PRESSURE/HYPOTENSION.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TO TREAT A BIG CYST DURING AN ENDOSCOPIC PROCEDURE (EUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT DEPLOYED IN THE SCOPE BUT NOT PROPERLY IN THE PATIENT. A SECOND AXIOS WAS DEPLOYED AND LATER THAT EVENING ON (B)(6) 2026, THE PATIENT WAS FEELING UNWELL AND COLLAPSED ON THE WARD. THE ON-CALL TEAM WAS CALLED IN FOR AN URGENT OESOPHAGO GASTRO DUODENOSCOPY (OGD) TO ACCESS THE PATIENT. IT WAS DISCOVERED THAT THERE WAS 300-400 ML OF BLOOD IN THE STOMACH. THE TEAM WAS ABLE TO SUCTION OUT THE BLOOD AND DISCOVERED A LARGE CLOT NEAR THE STENT. THERE WAS NO ACTIVE BLEEDING. THE PATIENT WAS REPORTED TO HAVE EXPERIENCED PERFORATION, BLEEDING, AND HYPOTENSION. THE PATIENT WAS ABLE TO BE DISCHARGED ON (B)(6) 2026 AND HAS FULLY RECOVERED.