BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONX AORTIC STANDARD 17

    MDR report key: 14467164 · Received May 22, 2022

    Report

    Report Number
    1649833-2022-00016
    Event Type
    Death
    Date Received
    May 22, 2022
    Report Date
    August 13, 2022
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE SURGEON STATED THE PEDIATRIC PATIENT THAT RECEIVED A 17MM ON-X AORTIC VALVE VIA COMPASSIONATE USE REQUEST HAD PASSED AWAY. HE MENTIONED THE CAUSE AS PANNUS ON THE VALVE BUT DID NOT ELABORATE.

    Description of Event or Problem · 0

    THE SURGEON STATED THE PEDIATRIC PATIENT THAT RECEIVED A 17MM ON-X AORTIC VALVE VIA COMPASSIONATE USE REQUEST HAD PASSED AWAY. HE MENTIONED THE CAUSE AS PANNUS ON THE VALVE BUT DID NOT ELABORATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563748 ONX AORTIC STANDARD 17 HEART VALVE, MECHANICAL LWQ ON-X LIFE TECHNOLOGIES, INC. ONXA-17

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death