BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 10953568 · Received December 5, 2020

    Report

    Report Number
    2025587-2020-03689
    Event Type
    Injury
    Date Received
    December 5, 2020
    Date of Event
    November 2, 2020
    Report Date
    December 4, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DE BACKER O ET AL. CORONARY ACCESS AFTER TAVR-IN-TAVR AS EVALUATED BY MULTIDETECTOR COMPUTED TOMOGRAPHY. JACC CARDIOVASC INTERV. 2020 NOV 9;13(21):2528-2538. DOI: 10.1016/J.JCIN.2020.06.016. AVAILABLE ONLINE 2 NOVEMBER 2020. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRO CODE NPT), EVOLUT R (PMA# P130021, PRO CODE NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 FROM A LITERATURE ARTICLE REGARDING CORONARY ACCESSIBILITY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR)-IN-TAVR USING MULTI-DETECTOR COMPUTED TOMOGRAPHY. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM 34 CENTERS. THE STUDY POPULATION INCLUDED 45 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 80 YEARS. OF THOSE, 35 PATIENTS WERE IMPLANTED WITH MEDTRONIC COREVALVE OR EVOLUT R TRANSCATHETER VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: TAVR-IN-TAVR (VALVE-IN-VALVE) DUE TO AORTIC STENOSIS, AORTIC REGURGITATION, OR MIXTURE OF AORTIC STENOSIS AND REGURGITATION (30 COREVALVE/EVOLUT R CASES); STROKE; AND REDUCED LEFT VENTRICULAR EJECTION FRACTION. IN ADDITION, THE PHYSICIAN/AUTHOR NOTED THAT FULLY IMPAIRED CORONARY ACCESS WAS OBSERVED IN 16 CASES WHERE THE FIRST TRANSCATHETER VALVE IMPLANTED WAS A COREVALVE OR EVOLUT R. BASED ON THE AVAILABLE INFORMATION, 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
    1419226 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R