BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X PROSTHETIC HEART VALVE

    MDR report key: 5538828 · Received March 31, 2016

    Report

    Report Number
    1649833-2016-70018
    Event Type
    Malfunction
    Date Received
    March 31, 2016
    Date of Event
    February 10, 2016
    Report Date
    April 27, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    DYE
    UDI-DI
    00851788001662
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS PER THE REQUEST SUBMITTED BY FDA MEDWATCH PROGRAM, THIS REPORT IS BEING RESUBMITTED AS REPORT NUMBER 1649833-2016--70018-1. THIS REPORT WAS INITIALLY SUBMITTED AS 1649833-2016-70014 - 1, MARCH 31, 2016. DESCRIPTION FROM MEDWATCH REPORT AS FOLLOWS: THIS IS A FOLLOW-UP REPORT TO THE ORIGINAL MOR NO. 1649833-2016-70014. EVENT OCCURRED IN ROMANIA. A LEAFLET WAS BROKEN WHILE ATTEMPTING ROTATION OF THE VALVE. THE VALVE HAS BEEN RETURNED AND INVESTIGATED. EVIDENCE SUGGESTS THAT THE HOUSING WAS ROTATED EITHER BY AN UNDER SIZE ROTATOR OR OTHER METHOD OUTSIDE THE SCOPE OF THE VALVE INSTRUCTIONS FOR USE (IFU) RESULTING IN LEAFLET FRACTURE AND SUBSEQUENT VALVE HOUSING DAMAGE. IN BRIEF, IT IS SUMMARIZED AS "IATROGENIC DAMAGE". THE IFU CLEARLY WARNS AGAINST USING UNDERSIZE ROTATORS OR OTHER NON-ON-X INSTRUMENT AS IT CAN RESULT IN DAMAGE. THIS WAS NOT A STRUCTURAL VALVE DYSFUNCTION CAUSED BY LATENT DEFECT IN THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196175 ON-X PROSTHETIC HEART VALVE MECHANICAL HEART VALVE DYE ON-X LIFE TECHNOLOGIES, INC. ONXANE 00851788001662

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown