BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 5586105 · Received April 18, 2016

    Report

    Report Number
    2025587-2016-00556
    Event Type
    Injury
    Date Received
    April 18, 2016
    Date of Event
    April 1, 2014
    Report Date
    April 18, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GLASER N, FRANCO-CERECEDA A, SARTIPY,U. ANN THORAC SURG 2014; 97:1314¿21 DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: INCLUDING ARTICLE TITLE IN CITATION. GLASER N, FRANCO-CERECEDA A, SARTIPY,U. LATE SURVIVAL AFTER AORTIC VALVE REPLACEMENT WITH THE PERIMOUNT VERSUS THE MOSAIC BIOPROSTHESIS. ANN THORAC SURG 2014; 97:1314¿21.

    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 VIA LITERATURE REVIEW REGARDING A STUDY PERFORMED TO COMPARE OUTCOMES FOLLOWING AORTIC VALVE REPLACEMENT (AVR) WITH AN EDWARDS PERIMOUNT VERSUS A MEDTRONIC MOSAIC BIOPROSTHESIS. THE STUDY POPULATION INCLUDED 1,219 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 73.6 YEARS), 355 OF WHICH WERE IMPLANTED WITH MEDTRONIC MOSAIC BIOPROSTHESIS (SERIAL NUMBERS NOT PROVIDED) AT A SINGLE SWEDISH INSTITUTION BETWEEN 2002 AND 2010. DURING A MEAN FOLLOW-UP OF 4.2 AND 6.9 YEARS, THERE WERE 177 DEATHS IN THE MOSAIC GROUP. THE UNADJUSTED SURVIVAL AT 1, 5, AND 8 YEARS WAS 92%, 80%, AND 57%, RESPECTIVELY, IN THE MOSAIC GROUP. NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS IN THE MOSAIC GROUP, THE UNADJUSTED FREEDOM FROM REOPERATION AT 1, 5, AND 8 YEARS WAS 99.7%, 98.4%, AND 97.0%, RESPECTIVELY. A TOTAL OF 10 PATIENTS REQUIRED REOPERATION WITH EXPLANTATION OR A VALVE-IN-VALVE PROCEDURE: 8 DUE TO UNSPECIFIED STRUCTURAL VALVE DYSFUNCTION (SVD) AND 2 DUE TO ENDOCARDITIS. REOPERATION FOR SVD WITHIN 48 MONTHS WAS PERFORMED IN 3 PATIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239497 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 30525

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention