BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC

    MDR report key: 8414424 · Received March 12, 2019

    Report

    Report Number
    2025587-2019-00906
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    January 28, 2019
    Report Date
    March 12, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    UDI-DI
    00885074253251
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 638RL28, SERIAL/LOT #: (B)(4), UDI#: (B)(4), PMA / 510(K) #: K061127. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCTS, 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 12 YEARS AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE AND MITRAL ANNULOPLASTY RING, THE VALVE AND RING WERE EXPLANTED. THE 25MM AORTIC VALVE WAS REPLACED WITH A 25MM VALVE OF A DIFFERENT MODEL. THE 28MM MITRAL RING WAS REPLACED WITH A 29MM VALVE. THE REASON(S) FOR REPLACEMENT WERE NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206365 MOSAIC HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 305U25 00885074253251

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention