BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALVEOLUS "AERO"

    MDR report key: 1232214 · Received November 13, 2008

    Report

    Report Number
    MW5008986
    Event Type
    Death
    Date Received
    November 13, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 13, 2008
    Manufacturer
    ALVEOLUS
    Product Code
    JCT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS SUBJECT WAS DIAGNOSED WITH TRACHEAL MALACIA AND SUBSEQUENTLY HAD A TRACHEAL STENT PLACED SURGICALLY IN 2008- "ALVEOLUS 18MM X 80 MM COVERED TRANSBRONCHIAL STENT"- . HE APPEARED TO RECOVER WELL POST-OPERATIVELY AND WAS DISCHARGED HOME FROM THE HOSP THE FOLLOWING DAY. SIX DAYS LATER, THE SUBJECT WAS HOME ALONE FOR APPROX 6 HOURS WHEN HE WAS FOUND COLLAPSED. RESPONDING PARAMEDICS/EMTS DID NOT ATTEMPT RESUSCITATION DUE TO OBVIOUS DEATH. EXAMINATION AT AUTOPSY REVEALED THE DECEDENT'S TRACHEAL STENT WAS OCCLUDED WITH MUCOUS, OBSTRUCTING HIS AIRWAY. THIS WAS DETERMINED TO BE HIS CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALVEOLUS "AERO" FULLY COVERED TRACHEOBRONCHIAL STENT JCT ALVEOLUS AERO 18 X 80 MM

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death