BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 12306952 · Received August 11, 2021

    Report

    Report Number
    2025587-2021-02518
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    October 14, 2019
    Report Date
    August 11, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WILDER T., ET AL. RAPID-DEPLOYMENT AORTIC VALVE REPLACEMENT AFTER AORTIC ROOT REPLACEMENT: A SAFE ALTERNATIVE TO REDO ROOT REPLACEMENT. J CARD SURG. 2020 JAN;35(1):222-225. DOI: 10.1111/JOCS.14278. PMID: 31609491. EPUB 2019 OCT 14. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 A CASE SERIES USING RAPID-DEPLOYMENT AORTIC VALVE PROSTHESES TO AVOID SURGICAL VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER. THE STUDY POPULATION INCLUDED THREE PATIENTS (TWO FEMALE/ONE MALE, MEAN AGE (B)(6)), TWO OF WHOM HAD PREVIOUSLY UNDERGONE SURGICAL AORTIC ROOT REPLACEMENT USING MEDTRONIC FREESTYLE AORTIC ROOT CONDUITS (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). FOR THE TWO MEDTRONIC FREESTYLE PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR TRANSCATHETER AORTIC VALVE REPLACEMENT DUE TO CONDUIT DEGENERATION. THE CONDUITS SHOWED MODERATE-SEVERE ANNULAR/VALVE LEAFLET CALCIFICATION, LARGE SUB-ANNULAR FIBROUS PANNI AND HIGH AORTIC TRANSVALVULAR GRADIENTS PER ECHOCARDIOGRAPHY. PATIENTS EXPERIENCED MODERATE-SEVERE AORTIC STENOSIS/INSUFFICIENCY WITH SYMPTOMS OF HEART FAILURE INCLUDING PROGRESSIVE FATIGUE AND SHORTNESS OF BREATH. THE PATIENTS WERE HOSPITALIZED AND UNDERWENT AORTIC VALVE REPLACEMENT. THE CALCIFIED FREESTYLE LEAFLET VALVES WERE EXCISED, ANNULAR DEBRIDEMENT WAS PERFORMED AND THEN THE FREESTYLE CONDUITS WERE SERIALLY DILATED. NON-MEDTRONIC TRANSCATHETER VALVES WERE THEN SEATED WITHIN THE CONDUITS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    1204357 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R