BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC HEART VALVES DIVISION

    MDR report key: 8401624 · Received March 7, 2019

    Report

    Report Number
    2025587-2019-00859
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    December 10, 2018
    Report Date
    March 7, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS 1 MONTH POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO REGURGITATION AND STRUCTURAL VALVE DETERIORATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194785 MEDTRONIC HEART VALVES DIVISION HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 31002901

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention