BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 9MM

    MDR report key: 16925044 · Received May 12, 2023

    Report

    Report Number
    3004450998-2023-00033
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    June 13, 2022
    Report Date
    May 12, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    NJK
    UDI-DI
    00896506002309
    PMA / PMN Number
    PMA P180007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT IS PARTICIPATING IN A POST APPROVAL STUDY. WHEN THE COPD EVENT INITIALLY OCCURRED ON (B)(6) 2022, THE PHYSICIAN RECORDED THE EVENT AS NOT DEVICE OR PROCEDURE RELATED. GYRUS ACMI, INC. FOLLOWED UP WITH THE PHYSICIAN TO OBTAIN PATIENT EVENT RESOLUTION INFORMATION AT WHICH TIME (B)(6) 2023) THE PHYSICIAN REVISED DETERMINATION AS PROCEDURE RELATED, INDICATING COPD PATIENTS DEVELOP EXACERBATIONS AFTER BRONCHOSCOPY. THE COPD IS THEREFORE BEING REPORTED. THERE WAS NO DEVICE RELATED MALFUNCTION. DEVICES WERE SUBSEQUENTLY REMOVED BECAUSE THE PATIENT EXPERIENCED NO CLINICAL BENEFIT. H3 OTHER TEXT : DEVICES WERE DISPOSED OF AT THE TIME OF REMOVAL.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A PATIENT HAD FOUR SPIRATION VALVES (ONE 5 MM, ONE 6MM, AND TWO 9MM) PLACED IN THE LEFT BOTTOM LOBE FOR THE TREATMENT OF EMPHYSEMA RESULTING IN COMPLETE OCCLUSION. A POST PROCEDURE CHEST X-RAY WAS TAKEN AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR POST PROCEDURE MONITORING. PATIENT WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2023. ON (B)(6) 2022 THE PATIENT VISITED THE EMERGENCY ROOM EXPERIENCING COPD EXACERBATION. THE PATIENT WAS TREATED WITH MEDICATION. NO HOSPITALIZATION WAS REQUIRED.  THE PHYSICIAN NOTED THE COPD EXACERBATION WAS NOT RELATED TO THE DEVICE; HOWEVER POSSIBLY RELATED TO THE INITIAL VALVE PLACEMENT PROCEDURE.  PATIENT WAS TREATED WITH MEDICATION THE COPD EXACERBATION RESOLVED WITHOUT SEQUELAE ON (B)(6) 2023. ON (B)(6) 2022, THE FOUR VALVES WERE REMOVED. THE PATIENT¿S VALVES WERE EVALUATED, AND THEY APPEARED TO BE IN PLACE BUT THE PHYSICIAN REPORTED THE PATIENT WAS NOT HAVING A CLINICAL RESPONSE TO THE VALVE PLACEMENT AND THE DECISION WAS MADE TO REMOVE THE VALVES. VALVES WERE DISPOSED OF AT TIME OF REMOVAL.  THERE WAS NO CONCERN OR COMPLAINT ASSOCIATED WITH THE VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042963 VALVE IN CARTRIDGE, 9MM SPIRATION VALVE NJK GYRUS ACMI, INC. SVS-V9-00 WS222496-01 00896506002309

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention