BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X AORTIC PROSTHETIC HEART VALVE

    MDR report key: 4999230 · Received August 11, 2015

    Report

    Report Number
    1649833-2015-00020
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    August 6, 2015
    Report Date
    August 10, 2015
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    UDI-DI
    00851788001426
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE RESPONSE DOES NOT DESCRIBE THE PROBLEM. THE VALVE WAS BROKEN DUE TO USER ERROR (IATROGENIC). NOT A FAILURE IN SERVICE. VALVE IS BEING RETURNED, HAS NOT ARRIVED YET. DETAILED INVESTIGATION IS PLANNED AND RESULTING INFO WILL BE PROVIDED IN A F/U REPORT. REVIEW OF DEVICE HISTORY RECORDS FOR THIS VALVE SHOWS THE VALVE WAS BUILT PER SPECS.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). ONE LEAFLET BROKE INTO 2 PIECES, INTRA-OPERATIVELY. KNOW TO BE IATROGENIC. NO ADVERSE EFFECT ON THE PT. FURTHER INFO WILL BE PROVIDED IN A F/U REPORT AFTER DETAILED INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524778 ON-X AORTIC PROSTHETIC HEART VALVE MECHANICAL HEART VALVE LWQ ON-X LIFE TECHNOLOGIES, INC. ONXACE 00851788001426

    Patients

    Seq Age Sex Outcome Treatment
    1