BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10022406 · Received May 4, 2020

    Report

    Report Number
    2025587-2020-01555
    Event Type
    Injury
    Date Received
    May 4, 2020
    Date of Event
    February 12, 2020
    Report Date
    May 4, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PALMERINI T ET AL. CORONARY PROTECTION TO PREVENT CORONARY OBSTRUCTION DURING TAVR: A MULTICENTER INTERNATIONAL REGISTRY. JACC CARDIOVASC INTERV. 2020 MAR 23;13(6):739-747. DOI: 10.1016/J.JCIN.2019.11.024. EPUB 2020 FEB 12. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 THE 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 AN EXAMINATION OF THE SAFETY AND EFFICACY OF CORONARY PROTECTION BY PREVENTIVE CORONARY WIRING AND STENTING ACROSS THE CORONARY OSTIA IN PATIENTS AT HIGH RISK FOR CORONARY OBSTRUCTION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM THE MULTI-CENTER CORPROTAVR (CORONARY PROTECTION DURING TAVR) REGISTRY BETWEEN APRIL 2011 AND FEBRUARY 2019. THE STUDY POPULATION INCLUDED 236 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 80 YEARS. OF THOSE, 76 WERE IMPLANTED WITH MEDTRONIC COREVALVE OR EVOLUT R TRANSCATHETER VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS WHO WERE TREATED WITH SELF-EXPANDING VALVES, 2 CASES OF CORONARY STENTING THROMBOSIS AND 2 CASES OF DEFINITE DELAYED CORONARY OCCLUSION OCCURRED THAT RESULTED IN DEATH FOR ALL 4 PATIENTS. IN ALL 4 CASES, THE SELF-EXPANDING VALVE WAS IMPLANTED VALVE-IN-VALVE IN A DEGENERATED SURGICAL VALVE. THE SELF-EXPANDING VALVES USED IN THE STUDY WERE COREVALVE/EVOLUT R, PORTICO, AND SYMETIS. THE TYPE OF SELF-EXPANDING VALVE THAT WAS IMPLANTED IN EACH OF THESE 4 PATIENTS WAS NOT IDENTIFIED. AN ADDITIONAL 23 DEATHS OCCURRED DURING THE 3-YEAR FOLLOW-UP PERIOD AMONG ALL PATIENTS INCLUDED IN THE STUDY POPULATION. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH ANY OF THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKE, MYOCARDIAL INFARCTION, AND MODERATE-SEVERE PARAVALVULAR LEAK. BASED ON THE AVAILABLE INFORMATION, 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
    485551 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening