BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 7432737 · Received April 16, 2018

    Report

    Report Number
    2025587-2018-00876
    Event Type
    Injury
    Date Received
    April 16, 2018
    Date of Event
    January 22, 2018
    Report Date
    April 16, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: S. KUERI ET AL. PERCEVAL SUTURELESS VALVE IN FAILING FREESTYLE BIOPROSTHESIS: A SERIES OF FOUR SURGICAL VALVES IN VALVE IMPLANTATIONS. THORAC CARDIOVASC SURG 2018; 66(S 01): S1-S110. DOI: 10.1055/S-0038-1628001. 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.   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 PERCEVAL SUTURELESS VALVE IN FAILING FREESTYLE BIOPROSTHESIS: A SERIES OF FOUR SURGICAL VALVES IN VALVE IMPLANTATIONS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2015 AND 2016. THE STUDY POPULATION INCLUDED 4 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 71 YEARS), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC FREESTYLE (SERIAL NUMBERS NOT PROVIDED).   AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: THREE PATIENTS PRESENTED WITH SEVERE AORTIC INSUFFICIENCY DUE TO CUSP RUPTURE AND ONE PATIENT PRESENTED WITH ENDOCARDITIS ISOLATED TO THE FREE CUSP EDGE OF THE BIOPROSTHESIS. BASED ON THE AVAILABLE INFORMATION, ALL WERE ATTRIBUTED TO MEDTRONIC PRODUCT.   NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275619 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention