BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 8232773 · Received January 10, 2019

    Report

    Report Number
    2025587-2019-00127
    Event Type
    Death
    Date Received
    January 10, 2019
    Date of Event
    December 4, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    UDI-DI
    00643169595026
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 95CS21, SERIAL/LOT #: (B)(4), UBD: 11-JAN-2021, UDI#: (B)(4), PMA/510(K) #: P970031 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 DURING IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE AND THIS 21MM MITRAL BIOPROSTHETIC VALVE, THE PATIENT PASSED AWAY DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26463 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 305U225 00643169595026

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death