AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

Additional Manufacturer Narrative

BLOCK H6: IMDRF DEVICE CODE A1502 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE.

Description of Event or Problem

THIS REPORT PERTAINS TO ONE OF TWO AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM USED IN THE SAME PATIENT. REFER TO COMPLAINT (B)(4) FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEMS WERE IMPLANTED TRANSGASTRIC TO FACILITATE PANCREATIC PSEUDOCYST DRAINAGE DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, A 15X10 STENT WAS INITIALLY DEPLOYED SUCCESSFULLY (SUBJECT OF THIS RECORD). AFTER DEPLOYMENT, THE PHYSICIAN ASSESSED THAT ADEQUATE DRAINAGE WAS NOT ACHIEVED DUE TO AN INAPPROPRIATE INITIAL SELECTION OF THE PUNCTURE SITE; AS A RESULT, THE PHYSICIAN ELECTED TO REMOVE THE DEPLOYED STENT. A SECOND 10X10 AXIOS STENT WAS SUBSEQUENTLY ADVANCED THROUGH ANOTHER PUNCTURE SITE FOLLOWING STANDARD TECHNIQUE. DURING DEPLOYMENT, UPON REACHING STEP 3 AND WHILE APPLYING SLIGHT TRACTION, THE STENT RELEASED PREMATURELY WITHOUT INTENTIONAL ACTIVATION OF THE SECOND FLANGE RELEASE (STEP 4). DESPITE THE PREMATURE RELEASE, THE DEVICE REMAINED PROPERLY IMPLANTED IN THE INTENDED POSITION. THEREFORE, THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.