AXIOS?

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A150103 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A0510 CAPTURES THE REPORTABLE EVENT OF SHEATH DIFFICULT TO RETRACT. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF A STENT-N-STENT TECHNIQUE WAS PERFORMED BY USING A PIGTAIL STENT TO COMPLETE THE PROCEDURE.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRIC TO PANCREAS TO TREAT A WALLED-OFF NECROSIS (WON) AND HYDROCELE DURING AN ENDOSCOPIC ULTRASOUND (EUS)-GUIDED GASTRIC BYPASS PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, SEVER RESISTANCE WAS ENCOUNTERED WHEN THE DISTAL FLANGE WAS ATTEMPTED TO BE DEPLOYED. THE AXIOS PROXIMAL FLANGE WAS THEN DEPLOYED BEFORE THE RELEASE OF STEP 4. THE AXIOS STENT REMAINED INSIDE THE CYST AND ABDOMINAL CAVITY, AND A GUIDEWIRE WAS INSERTED THROUGH THE GUIDEWIRE LUMEN OF THE AXIOS SYSTEM. A STENT-IN-STENT TECHNIQUE WAS PERFORMED, AND A PIGTAIL STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.