BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 7104815 · Received December 11, 2017

    Report

    Report Number
    2025587-2017-02389
    Event Type
    Injury
    Date Received
    December 11, 2017
    Date of Event
    June 8, 2017
    Report Date
    December 11, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YOSHIOKA, D. MD ET AL. RECENT SURGICAL RESULTS FOR ACTIVE ENDOCARDITIS COMPLICATED WITH PERIVALVULAR ABSCESS. CIRCULATION JOURNAL (2017) OCT 25;81(11):1721-1729; DOI 10.1253/CIRCJ.CJ-17-0355 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE CLINICAL RESULTS OF PATIENTS WHO UNDERWENT AORTIC VALVE REPLACEMENT DUE TO ENDOCARDITIS. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN 2009 AND 2016. THE STUDY POPULATION INCLUDED 226 PATIENTS, 5 OF WHICH WERE IMPLANTED WITH A FREESTYLE STENTLESS AORTIC ROOT. SERIAL NUMBERS WERE NOT PROVIDED. THE AORTIC ROOT REPLACEMENT POPULATION WAS PREDOMINANTLY MALE; MEAN AGE 63.1±14.5 YEARS. AMONG ALL PATIENTS IMPLANTED WITH AN AORTIC ROOT REPLACEMENT, ADVERSE EVENTS INCLUDED: NEUROLOGIC DETERIORATION, COMPLETE HEART BLOCK (CHB) WITH PERMANENT PACEMAKER IMPLANT AND PARAVALVULAR LEAK (PVL). BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884929 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention