BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 4242494 · Received November 11, 2014

    Report

    Report Number
    2025587-2014-00875
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 16, 2014
    Report Date
    November 21, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY ADDITIONAL INFORMATION WAS RECEIVED CORRECTING THE INITIAL REPORT FROM THE PROCEDURE. FOLLOWING IMPLANT OF ANOTHER MANUFACTURER'S MITRAL RING, THE PATIENT'S NATIVE AORTIC VALVE RETRACTED (NOT AN UNIDENTIFIED MEDTRONIC BIOPROSTHETIC VALVE AS ORGINALLY REPORTED). DUE THE EFFECT ON THE PATIENT'S NATIVE VALVE, THE NATIVE VALVE WAS EXCISED AND A MEDTRONIC BIOPROSTHETIC TISSUE VALVE WAS IMPLANTED TO SUCCESSFULLY RESOLVE THE PATIENT'S CONDITION WITH NO ADVERSE PATIENT EFFECTS. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT AN UNIDENTIFIED MEDTRONIC BIOPROSTHETIC AORTIC HEART VALVE HAD BEEN EXPLANTED DUE TO AORTIC INSU FFICIENCY THAT WAS THE RESULT OF THE IMPLANT OF ANOTHER MANUFACTURER¿S MITRAL REPAIR RING. FOLLOWING THE IMPLANT OF THE MITRAL RING, THE AORTIC VALVE BEGAN TO RETRACT. BOTH THE RING AND THE VALVE WERE EXPLANTED AND REPLACED. THERE WERE NO ISSUES WITH THE VALVE, OTHER THAN ITS PERFORMANCE BEING AFFECTED BY THE MITRAL RING IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727033 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 305019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention