BEUDAMED
    FDA Adverse Event Death Summary report: N

    AERO® TRACHEOBRONCHIAL STENT

    MDR report key: 20204675 · Received September 12, 2024

    Report

    Report Number
    1721504-2024-00063
    Event Type
    Death
    Date Received
    September 12, 2024
    Date of Event
    September 3, 2024
    Report Date
    September 10, 2024
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    JCT
    UDI-DI
    00884450703960
    PMA / PMN Number
    K082284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS NOT CONFIRMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO EXCEPTION DOCUMENTS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE ACCOUNT ALLEGES THAT DURING A TRACHEOBRONCHIAL STENT DEPLOYMENT PROCEDURE, THE CLINICIAN WAS UNABLE TO DEPLOY A STENT BY SQUEEZING THE DEPLOYMENT TRIGGER. THEY SWITCHED TO A NEW STENT AND HAD A SIMILAR ISSUE BUT WERE SUCCESSFUL IN DEPLOYING THE STENT, BUT THE STENT HAD ENFOLDED [INVAGINATED]. THE 12X40 STENT WAS PLACED VIA DIRECT VISION. NO DAMAGE WAS NOTED TO THE STENT OR THE DEVICE BEFORE OR DURING THE DEPLOYMENT ATTEMPT. THE CLINICIAN TRIED TO ADJUST THE STENT USING A BALLOON INFLATION TECHNIQUE AND ENDED UP PERFORATING THE TRACHEOBRONCHIAL WALL. THE PHYSICIAN STATES THE PATIENT WAS NOT IN GOOD CONDITION BEFORE THE PROCEDURE. THE 58-YEAR-OLD FEMALE PATIENT WHO SUFFERED FROM A LARGE CANCEROUS ENDOBRONCHIAL TUMOR LIKELY CONTRIBUTED TO THE PATIENT'S TRACHEOBRONCHIAL PERFORATION BY WEAKENING THE TRACHEAL WALL DURING THE BALLOON EXPANSION TECHNIQUE RESULTED IN PERFORATION. A CODE WAS INITIATED PER HOSPITAL PROTOCOLS BUT WAS UNSUCCESSFUL. THE PATIENT EXPIRED AT 4:15 PM THE SAME DAY. COD MASSIVE HEMORRHAGE. THE PATIENT ALSO EXPERIENCED HEMOPTYSIS 1 WEEK BEFORE THE ACTUAL STENT PLACEMENT AND UNDERWENT PHOTODYNAMIC THERAPY (PDT) TREATMENT 4 WEEKS BEFORE THAT ACTUAL STENT PLACEMENT. AN AUTOPSY IS NOT LIKELY DUE TO THE PATIENT'S DEATH BEING ATTENDED. THE DEVICE IS RETURNING FOR ENGINEERING EVALUATION. IN-STENT BALLOONING IS ACCEPTABLE PER IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557285 AERO® TRACHEOBRONCHIAL STENT PROSTHESIS, TRACHEAL, EXPANDABLE JCT MERIT MEDICAL SYSTEMS INC. E2982189 00884450703960

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Death| R INFLATION BALLOON