BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6430924 · Received March 24, 2017

    Report

    Report Number
    2025587-2017-00463
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    December 1, 2003
    Report Date
    February 27, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: RESULTS WITH THE FREESTYLE PORCINE AORTIC ROOT FOR RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION IN CHILDREN CITATION: ANN THORAC SURG (2003) 76:1889 ¿95 (DOI 10.1016/S0003-4975(03)01304-3) AUTHORS: KANTER, KIRK R. ET AL. 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.

    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 REVIEW REGARDING THE RESULTS OF THE USE OF FREESTYLE PORCINE AORTIC ROOT FOR RIGHT VEN TRICULAR OUTFLOW TRACT (RVOT) REPAIR IN CHILDREN. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1998 AND 2002. THE STUDY POPULATION INCLUDED 56 PATIENTS (MEAN AGE 11.8 YEARS), 43 OF WHICH WERE IMPLANTED WITH MEDTRONIC FREESTYLE AORTIC ROOT (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: POST-OPERATIVE MEDIASTINITIS THAT WAS TREATED WITH A MUSCLE FLAP CLOSURE. ENDOCARDITIS WAS ALSO NOTED IN A PATIENT WITH A PREVIOUSLY IMPLANTED HOMOGRAFT. IT WAS REPORTED THAT WHEN THE HOMOGRAFT WAS REMOVED AND REPLACED WITH THE FREESTYLE, THE HOMOGRAFT WAS POSITIVE FOR CANDIDA. SUBSEQUENTLY, THE PATIENT DEVELOPED ENDOCARDITIS AND WAS MEDICALLY TREATED. THE FREESTYLE WAS REPLACED 3.5 YEARS LATER DUE TO STENOSIS. OTHER ADVERSE EVENTS INCLUDED 23 INCIDENTS OF TRIVIAL TO MILD INSUFFICIENCY AND 4 INCIDENTS OF MODERATE INSUFFICIENCY AND 1 INCIDENT OF CLINICALLY SIGNIFICANT INCREASE GRADIENT MEASUREMENTS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213937 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention