BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPEN PIVOT MECHANICAL HEART VALVE

    MDR report key: 2171082 · Received July 8, 2011

    Report

    Report Number
    2134151-2011-00009
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    April 10, 2010
    Report Date
    June 15, 2011
    Manufacturer
    MEDTRONIC ATS, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P990046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: DEVICE HISTORY REVIEWED. RESULTS: DEVICE HISTORY REVIEW FOUND THE PRODUCT MET SPECS WHEN RELEASED FOR DISTRIBUTION. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS VALVE MET ALL MFG SPEC FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT DURING THE IMPLANT OF THIS MECHANICAL VALVE, A PARAVALVULAR LEAK WAS NOTED. THE VALVE WAS REMOVED AND A ANOTHER VALVE WAS IMPLANTED WITH NO ADVERSE PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPEN PIVOT MECHANICAL HEART VALVE LWQ MEDTRONIC ATS, INC. 500DM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention