BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-X AORTIC PROSTHETIC HEART VALVE

    MDR report key: 2624706 · Received January 16, 2010

    Report

    Report Number
    1649833-2010-00002
    Event Type
    Other
    Date Received
    January 16, 2010
    Date of Event
    December 8, 2009
    Report Date
    January 16, 2010
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE IS BEING EXAMINED AS OF THE DATE OF THIS REPORT, SO FINAL CONCLUSIONS ARE NOT YET AVAILABLE. THE FRACTURE SURFACES WILL BE EXAMINED. IT IS EXPECTED THAT THE CONCLUSION WILL INCLUDE CONFIRMATION THAT THE VALVE WAS MISHANDLED INTRAOPERATIVELY ((B)(6)). THIS CONCLUSION IS EXPECTED BECAUSE WE HAVE ARRIVED AT THIS CONCLUSION IN PAST BROKEN VALVE INVESTIGATIONS. A FINAL REPORT WILL NOT BE SENT IF THIS IS THE ONLY CONCLUSION. THE IFU CLEARLY WARNS AGAINST USE OF HARD INSTRUMENTS TO HANDLE THE VALVE. THE DISTRIBUTOR REINFORCED THIS WITH THE SURGEON.

    Description of Event or Problem · 1

    PER DISTRIBUTOR IN (B)(4), VALVE BROKE DURING IMPLANT PROCESS BECAUSE SURGEON PUSHED ON IT WITH FORCEPS AND BROKE A PIECE OF THE HOUSING. THE VALVE WAS NOT FITTING DUE TO A SIZING ERROR. SURGEON IS TAKING FULL RESPONSIBILITY. PATIENT NOT AFFECTED AND IS DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK