BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC

    MDR report key: 5088823 · Received September 18, 2015

    Report

    Report Number
    2025587-2015-00997
    Event Type
    Injury
    Date Received
    September 18, 2015
    Date of Event
    April 7, 2014
    Report Date
    September 30, 2015
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MISCONCEPTIONS, DIAGNOSTIC CHALLENGES AND TREATMENT OPPORTUNITIES IN BIOPROSTHETIC VALVE THROMBOSIS: LESSONS FROM A CASE SERIES CITATION: EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY 2015 47: 725¿32 (DOI:10.1093/EJCTS/EZU201) AUTHORS: SORIN V. PISLARUA, IMAD HUSSAINA, PATRICIA A. PELLIKKAA, JOSEPH J. MALESZEWSKIB, RICHARD D. HANNAA, HARTZELL V. SCHAFFC AND HEIDI M.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE WAS RETURNED AND NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AND ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW OF A RETROSPECTIVE STUDY PERFORMED TO EVALUATE THE TIMING, DIAGNOSTIC CRITERIA, AND TREATMENT STRATEGIES FOR THROMBOSIS IN BIOPROSTHETIC VALVES. THE STUDY POPULATION INCLUDED DATA FROM 31 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 60 ± 17 YEARS) FROM ONE CENTER BETWEEN 1997 AND 2013. FIFTEEN OF THESE PATIENTS WERE IMPLANTED WITH MEDTRONIC BIOPROSTHETIC VALVES FROM TWO DEVICE FAMILIES (SERIAL NUMBERS NOT REPORTED) IN THE AORTIC/ATRIO-VENTRICULAR (N=8), MITRAL (N=6), AND PULMONARY (N=1) POSITIONS. PATIENT 28 (MALE, (B)(6) WAS IMPLANTED WITH A MEDTRONIC 25-MM BIOPROSTHETIC VALVE IN THE AORTIC POSITION. THROMBOSIS WAS DIAGNOSED 412 DAYS POST-IMPLANT. FURTHER EVALUATION REVEALED INCREASED GRADIENTS AND IMMOBILE CUSPS WHICH WAS TREATED SURGICALLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    REQUESTS FOR ADDITIONAL INFORMATION PROVIDED NO FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619102 MOSAIC HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention