BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALVE IN CARTRIDGE, 7MM

    MDR report key: 16069834 · Received December 29, 2022

    Report

    Report Number
    3004450998-2022-00030
    Event Type
    Death
    Date Received
    December 29, 2022
    Report Date
    December 29, 2022
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    OAZ
    UDI-DI
    00896506002101
    PMA / PMN Number
    HDE H060002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCED ARTICLE WAS DISCOVERED FROM LITERATURE REVIEW ACTIVITIES. "REVELO A, KESHISHYAN S, EPELBAUM O,YAGHOUBIAN S, DELORENZO L, CHANDY D, CARROLL F, PAUL L,HARRIS K. DIAGNOSTIC AND THERAPEUTIC CHALLENGES IN MANAGING PERSISTENT AIR LEAKS. J THORAC DIS 2018;10(1):522-528. DOI: 10.21037/JTD.2018.01.43". THE ARTICLE WAS PUBLISHED IN 2018, HOWEVER DATES OF VALVE PLACEMENT AND ADVERSE EVENT WERE NOT PROVIDED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    PATIENT PRESENTED WITH ACUTE DYSPNEA DUE TO SPONTANEOUS RIGHT TENSION PNEUMOTHORAX REQUIRING URGENT CHEST TUBE PLACEMENT. TREATMENT WAS COMPLICATED BY PERSISTENT AIR LEAK (PAL) AND PNEUMONIA. PATIENT UNDERWENT RIGHT VIDEO-ASSISTED THORASCOPIC SURGERY (VATS). WHAT APPEARED TO BE A RIGHT MIDDLE LOBE ALVEOLAR-PLEURAL FISTULA WAS IDENTIFIED. ATTEMPTS TO TREAT WITH SEALANTS WERE UNSUCCESSFUL. ENDOBRONCHIAL VALVES (MANUFACTURER BRAND NOT KNOWN) WERE PLACED IN TREATMENT OF AIR LEAK. PLACEMENT OF AN INTRABRONCHIAL VALVE (IBV) IN THE RML BRONCHUS WAS COMPLETED. THE AIR LEAK SIGNIFICANTLY DECREASED, THEN RESOLVED WITHIN TWO DAYS. ONE MONTH LATER, SEPSIS AND A PLEURO-CUTANEOUS FISTULA WITH AIR LEAK DEVELOPED AT THE SITE OF THE PREVIOUS CHEST TUBE INSERTION. A CHEST TUBE WAS PLACED FOLLOWED BY AN ELOESSER WINDOW PROCEDURE TO DRAIN THE INFECTED PLEURAL SPACE. THE PATIENT REMAINED HOSPITALIZED FOR ABOUT TWO MONTHS AND EXPIRED FROM SEPTIC AND CARDIAC COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2612962 VALVE IN CARTRIDGE, 7MM SPIRATION VALVE OAZ GYRUS ACMI, INC. HUS-V7 UNKNOWN 00896506002101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| H