AXIOS?

Additional Manufacturer Narrative

BLOCK E1: INITIAL REPORTER CITY: (B)(6); REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK H6: IMDRF PATIENT CODE E1024 CAPTURES THE REPORTABLE EVENT OF PERITONITIS. IMDRF PATIENT CODE E0313 CAPTURES THE REPORTABLE EVENT OF THE DECREASE IN ALBUMIN LEVEL IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF THE MEDICAL INTERVENTION PERFORMED TO ADDRESS THE PERITONITIS. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSDUODENALLY TO THE GALLBLADDER FOR THE TREATMENT OF ACUTE CHOLECYSTITIS DURING A PANCREATIC CYSTIC GASTRIC (INTESTINAL) BYPASS PROCEDURE PERFORMED ON (B)(6) 2025. THE AXIOS STENT WAS SUCCESSFULLY IMPLANTED, AND NO DEVICE-RELATED PROBLEMS WERE IDENTIFIED AT THAT TIME. ON (B)(6) 2025; APPROXIMATELY 10 DAYS FOLLOWING THE PROCEDURE, NO IMPROVEMENT IN THE PATIENT'S CLINICAL CONDITION WAS REPORTED. THE PATIENT DEVELOPED PERITONITIS AND A DECREASE IN ALBUMIN LEVEL TO 1.6 WAS NOTED. THESE EVENTS WERE MANAGED WITH UNSPECIFIED CONSERVATIVE TREATMENT. THE RELATIONSHIP BETWEEN THE REPORTED PERITONITIS AND THE AXIOS STENT COULD NOT BE DETERMINED. ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT'S GENERAL CONDITION HAD ALREADY BEEN POOR PRIOR TO THE PROCEDURE AND MULTIPLE COMORBIDITIES WERE PRESENT. THE PATIENT SUBSEQUENTLY EXPIRED, AND THE REPORTED CAUSE OF DEATH WAS PERITONITIS.