BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIONAIR 3D STENT (PATIENT-SPECIFIC AIRWAY STENT)

    MDR report key: 11657266 · Received April 13, 2021

    Report

    Report Number
    3010197296-2021-03291
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 27, 2021
    Report Date
    March 31, 2021
    Manufacturer
    VISIONAIR SOLUTIONS
    Product Code
    NWA
    PMA / PMN Number
    K182743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE PROVIDED WITH THE FINISHED DEVICE DEFINES STENT MODIFICATION AS A CONTRAINDICATION.

    Description of Event or Problem · 1

    A PATIENT-SPECIFIC AIRWAY STENT WAS ORDERED ON (B)(6) 2021, FOR A PATIENT WITH RIGHT UPPER LOBECTOMY ((B)(6) 2019) AND DEMONSTRATING A KINKED RIGHT MAINSTEM BRONCHUS WITH >95% AIRWAY OBSTRUCTION. MULTIPLE STENTS HAD BEEN PREVIOUSLY PLACED AND FAILED TO ALLEVIATE THE PATIENT'S BRONCHIAL STENOSIS/MALACIA, INCLUDING STRAIGHT SILICONE STENTS (DUE TO GRANULATION/SECRETION OBSTRUCTION) AND SELF-EXPANDING METAL STENTS (PROXIMAL MIGRATION). THE PATIENT-SPECIFIC AIRWAY STENT (S/N: (B)(4)) WAS SHIPPED TO (B)(6) ON 15-FEB-2021. THE PATIENT-SPECIFIC AIRWAY STENT WAS A BIFURCATED (Y-STENT) BEGINNING WITHIN THE TRACHEA AND EXTENDING INTO THE LEFT AND RIGHT MAINSTEM BRONCHI. THE DATE OF PROCEDURE, THE STENT WAS BROUGHT TO THE OR WHERE THE PHYSICIAN OPENED THE SEALED BOX WITH THE STENT INSIDE, IN A SEALED PLASTIC BAG. THE PHYSICIAN MODIFIED THE STENT BY REMOVING THE LEFT MAINSTEM LIMB PRIOR TO IMPLANTATION DUE THE PATIENT'S STENOSIS INVOLVING THE RIGHT SIDE OF THE AIRWAY, WHICH RESULTED IN A STENT WITH A TRACHEAL COMPONENT AND RIGHT LIMB. THE DEVICE WAS THEN IMPLANTED ON THE DATE OF (B)(6) 2021. ON (B)(6) 2021, AT 2:00AM, THE PATIENT HAD COUGHED AND FELT THE STENT MOVE. EMS WAS CALLED AND THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT WHERE HE WAS INTUBATED FOR RESPIRATORY DISTRESS. THE PATIENT WAS THEN TRANSFERRED TO THE INSTITUTION WHERE THE STENT WAS IMPLANTED, WHERE A CT SCAN WAS COMPLETED AND SHOWED THAT THE STENT HAD MIGRATED PROXIMALLY IN THE PATIENT'S AIRWAY. THE STENT WAS EXPLANTED AND THE PATIENT WAS EXTUBATED IN THE SAME DAY. THE PATIENT WAS DISCHARGED AT HIS BASELINE RESPIRATORY STATUS THE NEXT MORNING, (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555119 VISIONAIR 3D STENT (PATIENT-SPECIFIC AIRWAY STENT) PROSTHESIS, TRACHEAL, PREFORMED/MOLDED NWA VISIONAIR SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R