BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 8126297 · Received December 3, 2018

    Report

    Report Number
    2025587-2018-03277
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    November 9, 2018
    Report Date
    December 3, 2018
    Manufacturer
    MEDTRONIC HEART VALVE DIVISION
    Product Code
    LWR
    UDI-DI
    00643169001503
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO ADD PMA / 510(K) # TO FIELD. 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. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THIS VALVE. THIS DEVICE WAS MANUFACTURED PER APPROVED AND RELEASED MAN UFACTURING PROCESSES AND MET ALL APPLICABLE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS AND TWO MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964467 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVE DIVISION 305U227 00643169001503

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention