BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 11382420 · Received February 25, 2021

    Report

    Report Number
    2025587-2021-00686
    Event Type
    Injury
    Date Received
    February 25, 2021
    Date of Event
    July 29, 2020
    Report Date
    February 25, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ASLAN S ET AL. USEFULNESS OF MEMBRANOUS SEPTUM LENGTH IN THE PREDICTION OF MAJOR CONDUCTION DISTURBANCES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT WITH DIFFERENT DEVICES. KARDIOL POL. 2020 OCT 23;78(10):1020-1028. DOI: 10.33963/KP.15538. EPUB 2020 JUL 29. 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 FROM A LITERATURE ARTICLE REGARDING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) RELATED NEW ONSET LEFT BUNDLE BRANCH BLOCK (LBBB) AND PERMANENT PACEMAKER IMPLANTATION RATES IN PATIENTS WITH SHORT MEMBRANOUS SEPTUM. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2017 AND FEBRUARY 2020. THE STUDY POPULATION INCLUDED 140 PATIENTS WHO UNDERWENT TAVR WITH A NON-MEDTRONIC TRANSCATHETER VALVE OR MEDTRONIC EVOLUT R TRANSCATHETER VALVE (PREDOMINANTLY FEMALE, MEAN AGE 78.8 YEARS). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, TWO PERIOPERATIVE DEATHS OCCURRED (WITHIN TWENTY-FOUR HOURS AFTER TAVR). THE MANUFACTURER OF THE VALVES IMPLANTED IN THESE TWO PATIENTS WAS NOT DISCLOSED. MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: SECOND VALVE IMPLANTED DURING TAVR DUE TO VALVE DISLODGEMENT; PERMANENT PACEMAKER IMPLANTATION FOR COMPLETE HEART BLOCK, MOBITZ TYPE II SECOND-DEGREE ATRIOVENTRICULAR BLOCK, OR LBBB WITH A PROLONGED PR INTERVAL AND ATRIAL FIBRILLATION WITH SLOW VENTRICULAR RESPONSE RESULTING IN HEMODYNAMIC INSTABILITY; AND NEW ONSET LBBB WITHOUT PACEMAKER IMPLANTATION. 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
    279020 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention