BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 6661576 · Received June 22, 2017

    Report

    Report Number
    2025587-2017-01020
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    November 25, 2016
    Report Date
    July 7, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RAFIQ S ET AL. ANTITHROMBOTIC THERAPY AFTER BIOPROSTHETIC AORTIC VALVE IMPLANTATION: WARFARIN VERSUS ASPIRIN, A RANDOMIZED CONTROLLED TRIAL. THROMB RES 150, 104-110. 2016 NOV 25. DOI: 10.1016/J.THROMRES.2016.11.021 EARLIEST 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 THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    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 REGARDING ANTITHROMBOTIC THERAPY AFTER BIOPROSTHETIC AORTIC VALVE IMPLANT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2005 AND 2012. THE STUDY POPULATION INCLUDED 328 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 73 YEARS), 303 OF WHICH WERE IMPLANTED WITH MEDTRONIC MOSAIC (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MYOCARDIAL INFARCTION, STROKE, MAJOR BLEEDING REQUIRING RE-EXPLORATION, PERICARDIAL EFFUSION REQUIRING DRAINAGE, ATRIAL FIBRILLATION, CARDIOVERSION, AND PARAVALVULAR LEAK (PVL). MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE OBSERVED ADVERSE EVENTS, AND ALSO PROVIDED THE MEAN PATIENT WEIGHT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441825 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 30525

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention