AXIOS Stent and Electrocautery Enhanced Delivery System

Description of Event or Problem

It was reported to Boston Scientific Corporation that an Axios Stent and Electrocautery Enhanced Delivery System was intended to be implanted in the transduodenal to treat pseudocyst in an Endoscopic Ultrasound (EUS) procedure performed on (b)(6) 2026.During the procedure, the physician stated that the second flange did not unfold. The physician was able to remove the stent by using forceps. The procedure was able to be completed by using another of the same device. There were no patient complications reported as a result of this event.

Additional Manufacturer Narrative

Block H6: IMDRF Device Code A150101 captures the reportable event of Stent Failure To Expand.Block H11:Investigation Results:With all available information, Boston Scientific Corporation concludes that the reported event of Stent Failure To Expand was unable to be confirmed. There is not enough evidence to determine whether the reported events Stent Failure To Expand and Additional Device Required were related to physician technique, procedural factors, or a potential device malfunction.Device History Record Review:It was confirmed that this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device Technical Analysis:The complaint device was not returned therefore; product analysis could not be performed.Similar Complaint Review:A Similar Complaint Review was completed. There were no emerging trends identified that warrant further escalation.Investigation Conclusion:Based on all gathered information and the results of the product analysis, the complaint investigation conclusion code of Cause Not Established.