BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-X MITRAL PROSTHETIC HEART VALVE

    MDR report key: 4254102 · Received November 12, 2014

    Report

    Report Number
    1649833-2014-00013
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    September 17, 2014
    Report Date
    November 11, 2014
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR RETURN. ALTHOUGH NOT EXPECTED, IF RELEVANT FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THE FOLLOWING: AS PART OF THEIR PATIENT TRACKING PROCEDURE, THEY RECEIVED INFORMATION FROM (B)(6) HOSPITAL THAT ONXM-27/29 S/N (B)(4) MITRAL VALVE THAT HAD BEEN IMPLANTED ON (B)(6) 2008 WAS REPLACED WITH A DIFFERENT BRAND VALVE ON (B)(6) 2014. ANY FURTHER DETAILS ARE NOT AVAILABLE. THE DISTRIBUTOR IS NOT ABLE TO GET INFORMATION ON THE REASON FOR RE-OPERATION. THE REASON THIS IS BEING REPORTED IS BECAUSE ON-X LIFE TECHNOLOGIES, INC. BELIEVES THAT THE RE-OPERATION WAS DONE BECAUSE OF A VALVE-RELATED ADVERSE EVENT. AT THIS POINT, ALL VALVE-RELATED ADVERSE EVENTS REPORTED THUS FAR ARE ON THE LIST OF EXPECTED EVENTS SHOWN IN SECTION 5 OF THE IFU, AND ARE OCCURRING WELL-WITHIN EXPECTED RATES. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE SHOWS THE VALVE WAS MANUFACTURED IN ACCORDANCE WITH SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729791 ON-X MITRAL PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other