BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 12409200 · Received September 1, 2021

    Report

    Report Number
    2025587-2021-02722
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    September 18, 2020
    Report Date
    September 1, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PASALA, T. ET AL. HINGE POINT-BASED ANNULAR PLANE WITH ABNORMAL AORTIC CUSPS IN TRANSCATHETER AORTIC VALVE REPLACEMENT. EU ROINTERVENTION. 2021; 16(7):549-553 DOI: 10.4244/EIJ-D-19-00760 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 USE OF HINGE POINT-BASED ANNULAR PLANE WITH ABNORMAL AORTIC CUSPS IN TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A SINGLE CENTER. TWO PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUTR TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. NO PATIENT INFORMATION OR NO SERIAL NUMBERS WERE PROVIDED. NO DEATHS WERE REPORTED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: SEVERE PARAVALVULAR LEAK (PVL) IN ONE PATIENT AND VALVE DISLODGMENT TREATED WITH VALVE-IN-VALVE IN A DIFFERENT PATIENT. BASED ON THE AVAILABLE INFORMATION A MEDTRONIC PRODUCT WAS 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
    1301723 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention