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 DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.

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 IN THE TRANSGASTRIC TO TREAT A PSEUDOCYST DURING A PSEUDOCYST DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT THE STENT PROXIMAL FLANGE FAILED TO DEPLOY. THE DISTAL FLANGE WAS ABLE TO BE DEPLOYED BUT AFTER AWHILE THE STENT MIGRATED TO THE STOMACH. IT WAS NOTED THAT THERE WAS STRONG RESISTANCE WHEN THE PHYSICIAN TRIED TO DEPLOY THE PROXIMAL FLANGE. THE PHYSICIAN WAS ABLE TO REMOVE THE STENT BY USING FORCEPS AND THE PROCEDURE WAS ABLE TO BE COMPLETED BY USING ANOTHER OF THE SAME DEVICE. THE PROCEDURE WAS PROLONGED FOR ABOUT 5 MINUTES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT WAS MENTIONED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN BUT THE PATIENT WAS DISCHARGED WITHOUT ANY SIGNIFICANT ISSUES AND REMAINED FREE OF SYMPTOMS.