VISIONAIR 3D STENT

Additional Manufacturer Narrative

IT WAS REPORTED THAT A PATIENT RECEIVED A VISIONAIR 3D STENT AND DEVELOPED AN IRRITATION IN THE AIRWAY THAT WAS EXPLANTED. DEVICE NOT RETURNED. DEVICE HISTORY RECORDS WERE REVIEWED. THERE WERE NO REPORTED ANOMALIES WITH THE MATERIALS, MANUFACTURING, CLEANING, OR PACKAGING PROCESS. NCMS WERE REVIEWED. THERE WERE NO REPORTED ISSUES WITH MATERIALS, MANUFACTURING, CLEANING OR PACKAGING. COMPLAINTS WERE REVIEWED. THERE ARE NO OTHER SIMILAR ADVERSE EVENTS REPORTED FOR THE VISIONAIR 3D STENT. IRRITATION OF THE AIRWAY AND/OR INFLAMMATORY REPONSE ARE KNOWN RISKS AND LISTED IN VISIONAIR INSTRUCTIONS FOR USE. BASED ON THE PROVIDED INFORMATION, IT IS NOT POSSIBLE TO ATTRIBUTE THE REPORTED ADVERSE EVENT TO A DEVICE FAILURE OR DEVICE-RELATED ISSUE.

Description of Event or Problem

PATIENT HAD A REPORTED IRRITATION TO AIRWAY AFTER IMPLANTATION OF VISIONAIR 3D STENT.