BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X PROSTHETIC HEART VALVE

    MDR report key: 5470251 · Received March 1, 2016

    Report

    Report Number
    1649833-2016-70009
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Report Date
    April 27, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    DYE
    UDI-DI
    00851788001303
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 1649833-2016-70009-1. THIS REPORT WAS SUBMITTED AS 1649833-2016-70001-1, MARCH 1, 2016. DESCRIPTION FROM ORIGINAL FOLLOW-UP MEDWATCH REPORT AS FOLLOWS: THIS IS A FOLLOW-UP REPORT TO THE ORIGINAL MDR NO. 1649833-2016-70001. EVENT OCCURRED IN (B)(6). ORIGINAL REPORT STATED: "(B)(4) DISTRIBUTOR REPORTED THAT THEY RECEIVED A COMPLAINT FROM DR. (B)(6) WHO IMPLANTED A ONXMC-25/33 AND FOUND THAT A LEAFLET DID NOT WORK PROPERLY HE EXPLANTED THE VALVE AND FOUND THAT THE LEAFLET HAD NO MOTION PROBLEM HE REQUESTED INVESTIGATION". THE VALVE HAS BEEN RETURNED AND RE-TESTED. THE VALVE WAS FOUND TO FUNCTION PER SPECIFICATIONS. IT IS CONCLUDED THAT THE VALVE WAS NOT DEFECTIVE. A LEAFLET MOTION PROBLEM WILL OCCUR WHEN THERE IS INTERFERENCE WITH LEAFLET MOVEMENT, TYPICALLY FROM ANATOMIC INTERFERENCE. THIS CONDITION HAS BEEN REPORTED AT A VERY LOW LEVEL, APPROXIMATELY 0.0%. IN ALL CASES WHERE WE HAVE BEEN ABLE TO RE-TEST THE RETURNED PRODUCT, IT HAS BEEN FOUND TO MEET SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128944 ON-X PROSTHETIC HEART VALVE MECHANICAL HEART VALVE DYE ON-X LIFE TECHNOLOGIES, INC. ONXMC 00851788001303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention