Advanix? Biliary

Description of Event or Problem

It was reported to Boston Scientific Corporation that an Advanix RX Biliary Preloaded Stent was to be implanted in the left hepatic duct to treat stenosis during an Endoscopic Retrograde Cholangiopancreatography Procedure (ERCP) performed on (b)(6) 2026.During the procedure, resistance was encountered during stent deployment. It was noted that the internal metal guidewire of the delivery system had fractured and was no longer traversing the entire length of the catheter. As a result, the stent could not be deployed. During removal of the device, a portion of the black inner catheter became visible. The exposed portion was grasped with a snare; however, it fractured, and a segment remained attached to the stent. The push catheter was also reported to have fractured. The procedure was subsequently completed using another device of the same model. There were no patient complications reported as a result of this event and the patient condition following the procedure was reported to be good.Note: The Advanix Biliary stent had expired on (b)(6) 2025 but was used on (b)(6) 2026.

Additional Manufacturer Narrative

Block H6:IMDRF Device Code A0401 captures the reportable event of guide catheter break.IMDRF Impact Code F2301 captures the reportable event of the additional device required to retrieve the broken device fragment.