BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X PROSTHETIC HEART VALVE

    MDR report key: 5536466 · Received March 30, 2016

    Report

    Report Number
    1649833-2016-70017
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Date of Event
    November 6, 2015
    Report Date
    April 27, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    DYE
    UDI-DI
    00851788001280
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    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--70017-1. THIS REPORT WAS INITIALLY SUBMITTED AS FOLLOW-UP REPORT 1649833-2016-70030 - 1, MARCH 30, 2016. DESCRIPTION FROM MEDWATCH REPORT AS FOLLOWS: THIS IS A FOLLOW-UP REPORT TO THE ORIGINAL MOR NO. 1649833-2015-70030. EVENT OCCURRED IN USA. ORIGINAL REPORT STATED LEAFLET BROKE WHILE ROTATING THE VALVE. THE VALVE HAS BEEN RETURNED AND INVESTIGATED AND IT WAS FOUND THAT THE LEAFLET HAD BEEN PUSHED OUT OF ITS SOCKET WHILE ATTEMPTING ROTATION, AND IN THE PROCESS THE HOUSING COATING WAS FRACTURED IN A NUMBER OF AREAS. THE CONCLUSION IS THAT THE DAMAGE RESULTED FROM USING A ROTATOR THAT IS SMALLER THAN THE VALVE SIZE, ALLOWING ROTATIONAL FORCES TO BE APPLIED TO THE LEAFLETS. THE CORRECT SIZE ROTATOR APPLIES ROTATIONAL FORCES SAFELY TO STRONG FEATURES ON THE HOUSING INTERIOR. IN BRIEF, IT IS SUMMARIZED AS "IATROGENIC DAMAGE". THE IFU CLEARLY WARNS AGAINST USING UNDERSIZED ROTATORS 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
    192727 ON-X PROSTHETIC HEART VALVE MECHANICAL HEART VALVE DYE ON-X LIFE TECHNOLOGIES, INC. ONXM 00851788001280

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown