BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIR 3D STENT

    MDR report key: 24821147 · Received April 8, 2026

    Report

    Report Number
    3010197296-2026-00001
    Event Type
    Injury
    Date Received
    April 8, 2026
    Report Date
    April 8, 2026
    Manufacturer
    VISIONAIR SOLUTIONS
    Product Code
    NWA
    UDI-DI
    00860011822608
    PMA / PMN Number
    K213969
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446392 VISIONAIR 3D STENT TRACHEAL/BRONCHIAL STENT NWA VISIONAIR SOLUTIONS 0010-0126 Y.2512034.B.01C 00860011822608

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention