BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC

    MDR report key: 5088819 · Received September 18, 2015

    Report

    Report Number
    2025587-2015-00995
    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). TITLE: 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. CONNOLLYA.

    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 +/- 7 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 26 (MALE, (B)(6)) WAS IMPLANTED WITH A MEDTRONIC 25-MM BIOPROSTHETIC VALVE IN THE AORTIC POSITION. THROMBOSIS WAS DIAGNOSED 1429 DAYS POST-IMPLANT. FURTHER EVALUATION REVEALED INCREASED GRADIENTS AND THICKENED CUSPS WITH DECREASED MOBILITY WHICH WAS TREATED SURGICALLY. NO ADDITIONAL 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
    619195 MOSAIC HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention