BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE IN CARTRIDGE, 7MM

    MDR report key: 12973333 · Received December 9, 2021

    Report

    Report Number
    3004450998-2021-00036
    Event Type
    Injury
    Date Received
    December 9, 2021
    Date of Event
    April 30, 2019
    Report Date
    December 9, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    NJK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEVEN SPIRATION VALVES (1X PIV-V9, 4X PIV-V7, 2X PIV-V6) WERE PLACED IN THE PATIENT. A TOTAL OF SEVEN EVENT REPORTS WERE FILED SEPARATELY, ONE REPORT FOR EACH DEVICE. EVENT WAS INITIALLY REPORTED BY (B)(6) STUDY PRINCIPAL INVESTIGATOR AS BEING UNRELATED TO DEVICE OR PROCEDURE. THE (B)(6) CLINICAL EVENTS COMMITTEE REVIEW, HELD APPROXIMATELY 6 MONTHS POST RESOLUTION OF THE EVENT, CONCLUDED EVENT WAS POSSIBLY RELATED TO THE DEVICE AND IS THEREFORE BEING REPORTED AT THIS TIME. DEVICE WAS NOT REMOVED FROM PATIENT.

    Additional Manufacturer Narrative · 0

    SEVEN SPIRATION VALVES (1X PIV-V9, 4X PIV-V7, 2X PIV-V6) WERE PLACED IN THE PATIENT. A TOTAL OF SEVEN EVENT REPORTS WERE FILED SEPARATELY, ONE REPORT FOR EACH DEVICE. EVENT WAS INITIALLY REPORTED BY (B)(4) STUDY PRINCIPAL INVESTIGATOR AS BEING UNRELATED TO DEVICE OR PROCEDURE. THE (B)(4) CLINICAL EVENTS COMMITTEE REVIEW, HELD APPROXIMATELY 6 MONTHS POST RESOLUTION OF THE EVENT, CONCLUDED EVENT WAS POSSIBLY RELATED TO THE DEVICE AND IS THEREFORE BEING REPORTED AT THIS TIME. DEVICE WAS NOT REMOVED FROM PATIENT.

    Description of Event or Problem · 0

    (B)(6) CLINICAL STUDY SUBJECT HAD SEVEN SPIRATION VALVES (1X PIV-V9, 4X PIV-V7, 2X PIV-V6) PLACED FOR TREATMENT OF EMPHYSEMA. APPROXIMATELY TWO AND A HALF YEARS POST-PROCEDURE, SUBJECT EXPERIENCED RESPIRATORY FAILURE IN VALVE-TREATED LOBE (RIGHT LOWER LOBE) THAT REQUIRED HOSPITALIZATION AND VENTILATION SUPPORT. RESPIRATORY FAILURE WAS RESOLVED WITHOUT SEQUELAE AFTER A NINE-DAY HOSPITAL STAY.

    Description of Event or Problem · 0

    (B)(4) CLINICAL STUDY SUBJECT HAD SEVEN SPIRATION VALVES (1X PIV-V9, 4X PIV-V7, 2X PIV-V6) PLACED FOR TREATMENT OF EMPHYSEMA. APPROXIMATELY TWO AND A HALF YEARS POST-PROCEDURE, SUBJECT EXPERIENCED RESPIRATORY FAILURE IN VALVE-TREATED LOBE (RIGHT LOWER LOBE) THAT REQUIRED HOSPITALIZATION AND VENTILATION SUPPORT. RESPIRATORY FAILURE WAS RESOLVED WITHOUT SEQUELAE AFTER A NINE-DAY HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869474 VALVE IN CARTRIDGE, 7MM SPIRATION VALVE NJK GYRUS ACMI, INC PIV-V7 W01367-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R