BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 12091600 · Received June 30, 2021

    Report

    Report Number
    2025587-2021-02035
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    October 23, 2020
    Report Date
    June 30, 2021
    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: KITAMURA M, ET AL. SYSTEMATIC USE OF INTENTIONAL LEAFLET LACERATION TO PREVENT TAVI-INDUCED CORONARY OBSTRUCTION: FEASIBILITY AND EARLY CLINICAL OUTCOMES OF THE BASILICA TECHNIQUE. EUROINTERVENTION. 2020 OCT 23;16(8):682-690. DOI: 10.4244/EIJ-D-20-00386. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 THE INTENTIONAL LEAFLET LACERATION TO PREVENT CORONARY OBSTRUCTION AFTER A TRANSCATHETER AORTIC VALVE IMPLANT (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2018 AND 2020. THE STUDY POPULATION INCLUDED 21 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 78 YEARS), 1 OF WHOM WAS PREVIOUSLY IMPLANTED WITH MEDTRONIC FREESTYLE AORTIC ROOT, 1 OF WHOM WAS PREVIOUSLY IMPLANTED WITH A MEDTRONIC COREVALVE AND 18 OF WHOM WERE IMPLANTED VALVE IN VALVE WITH A MEDTRONIC EVOLUTR. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS NO DEATHS WERE REPORTED. AMONG ALL PATIENTS WITH A PREVIOUSLY IMPLANTED AORTIC ROOT OR TRANSCATHETER AORTIC VALVE, ADVERSE EVENTS INCLUDED: STENOSIS, AORTIC REGURGITATION AND INCREASED GRADIENT MEASUREMENTS. BASED ON THE AVAILABLE INFORMATION A MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL PATIENTS WITH A TRANSCATHETER VALVE IMPLANTED VALVE-IN-VALVE, ADVERSE EVENTS INCLUDED: MILD PARAVALVULAR LEAK (PVL), PATIENT-PROSTHESIS MISMATCH (PPM) WITHOUT INTERVENTION AND INCREASED GRADIENT MEASUREMENTS. BASED ON THE AVAILABLE INFORMATION A MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993377 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention