AXIOS

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 AN ENDOSCOPIC ULTRASOUND (EUS) 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 OF THE AXIOS STENT WAS DEPLOYED WITHIN THE ENDOSCOPE BUT WAS DIFFICULT TO RELEASE. THE PHYSICIAN SUBSEQUENTLY RELEASED THE STENT FROM THE SCOPE; HOWEVER, THE STENT ADVANCED FORWARD AND MIGRATED INTO THE COLLECTION. A 15X10 MM AXIOS STENT WAS THEN DEPLOYED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT RETURNED FOR A SCHEDULED FOLLOW-UP NECROSECTOMY TWO DAYS AFTER STENT PLACEMENT, DURING WHICH THE INITIALLY MISDEPLOYED STENT WAS RETRIEVED USING GRASPING FORCEPS. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE F2202CAPTURES THE REPORTABLE EVENT OF AN ADDITIONAL ENDOSCOPIC PROCEDURE (NECROSECTOMY) TO RETRIEVE THE MISDEPLOYED STENT. IMDRF DEVICE CODE F2301 CAPTURES THE REPORTABLE EVENT OF AN ADDITIONAL DEVICE REQUIRED (GRASPERS) TO RETRIEVE THE MISDEPLOYED STENT.