BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC

    MDR report key: 8056669 · Received November 9, 2018

    Report

    Report Number
    2025587-2018-03020
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 11, 2018
    Report Date
    November 26, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    UDI-DI
    00721902694738
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 NINE YEARS AND ELEVEN MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, A NON-MEDTRONIC VASCULAR PLUG WAS PLACED TO ADDRESS SEVERE PARAVALVULAR LEAK (PVL). APPROXIMATELY TWO WEEKS POST IMPLANT OF THE VASCULAR PLUG, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR THE VALVE-IN-VALVE PROCEDURE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896739 MOSAIC HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 305C21 00721902694738

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention