BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 1982679 · Received February 1, 2011

    Report

    Report Number
    2025587-2011-00008
    Event Type
    Injury
    Date Received
    February 1, 2011
    Report Date
    January 11, 2011
    Manufacturer
    MEDTRONIC HEART VALVE, INC.
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED. RESULTS: NO DEVICE RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. SHOULD THE PRODUCT BE RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS BIOPROSTHESIS, IMPLANTED FOR ALMOST THREE YEARS, WAS EXPLANTED DUE TO STENOSIS AND HIGH GRADIENTS. INTRA-OPERATIVELY, THE VALVE DID NOT EXHIBIT SIGNIFICANT DYSFUNCTION. THERE WERE NO ADVERSE PT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVE, INC. 305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention