BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X PROSTHETIC HEART VALVE

    MDR report key: 5475527 · Received March 2, 2016

    Report

    Report Number
    1649833-2016-70011
    Event Type
    Malfunction
    Date Received
    March 2, 2016
    Date of Event
    January 19, 2016
    Report Date
    April 27, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    DYE
    UDI-DI
    00851788001464
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    AS PER THE REQUEST SUBMITTED BY FDA MEDWATCH PROGRAM, THIS REPORT IS BEING RESUBMITTED AS REPORT NUMBER 1649833-2016--70011-1. THIS REPORT WAS INITIALLY SUBMITTED AS 1649833-2016-70003 - 1, MARCH 2, 2016. DESCRIPTION FROM MEDWATCH REPORT AS FOLLOWS: THIS IS A FOLLOW-UP REPORT TO THE ORIGINAL MOR NO. 1649833-2016-70003. EVENT OCCURRED IN (B)(6) ORIGINAL REPORT STATED: "SURGEON NOTIFIED SALES REP THAT A PIECE OF CARBON FROM THE VALVE HOUSING BROKE OFF WHILE THE IMPLANT WAS BEING COMPLETED. THE SURGEON STATED THAT THE CHIP IN THE VALVE HOUSING WAS NOTICED RIGHT AFTER SHE HAD CUT ALL THE SUTURES AFTER THE VALVE HAD BEEN PLACED. SHE DEEMED THIS UNSATISFACTORY NECESSITATING EXCISION AND SUBSEQUENT PLACEMENT OF A SECOND PROSTHESIS AND THE SURGERY WAS COMPLETED". THE VALVE HAS BEEN RETURNED AND EVALUATED. THE CONCLUSION IS THAT THE VALVE WAS BROKEN DUE TO MISHANDLING POSSIBLY USING A STAINLESS STEEL INSTRUMENT SUCH AS A HEMOSTAT. IN BRIEF, IT IS SUMMARIZED AS "IATROGENIC". THE IFU CLEARLY WARNS AGAINST USING SUCH INSTRUMENTS ON THE VALVE AS IT CAN RESULT IN BREAKAGE OF THE CARBON. THIS WAS NOT A STRUCTURAL VALVE DYSFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132145 ON-X PROSTHETIC HEART VALVE MECHANICAL HEART VALVE DYE ON-X LIFE TECHNOLOGIES, INC. ONXACE 00851788001464

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Required Intervention