BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8310068 · Received February 6, 2019

    Report

    Report Number
    2025587-2019-00511
    Event Type
    Injury
    Date Received
    February 6, 2019
    Date of Event
    November 15, 2018
    Report Date
    February 6, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GONSKA B ET AL. INFLUENCE OF PERMANENT PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION WITH NEW-GENERATION DEVICES. NETH HEART J. 2018 DEC;26(12):620-627. DOI: 10.1007/S12471-018-1194-1. EPUB 2018 NOV 15. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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. (B)(4). 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 ONE-YEAR OUTCOMES ASSOCIATED WITH PERMANENT PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION IN PATIENTS TREATED WITH THE NEW-GENERATION DEVICES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 2014 AND SEPTEMBER 2016. THE STUDY POPULATION INCLUDED 612 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 80 YEARS), 27 OF WHICH WERE IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 5 IN-HOSPITAL DEATHS OCCURRED (BETWEEN THE 20TH AND 51ST DAY AFTER THE PROCEDURE) AND THE ALL-CAUSE MORTALITY RATE DURING THE ONE-YEAR FOLLOW-UP PERIOD WAS 12.4%. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE LIMITED AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THESE DEATHS. NEW PERMANENT PACEMAKER OR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTATION WAS REQUIRED IN 168 PATIENTS DUE TO: FIRST, SECOND- OR THIRD-DEGREE ATRIOVENTRICULAR BLOCK, COMPLETE LEFT BUNDLE BRANCH BLOCK, COMPLETE RIGHT BUNDLE BRANCH BLOCK, TRIFASCICULAR BLOCK, BRADYARRHYTHMIA WITH ATRIAL FIBRILLATION, SINUS ARREST, AND RESUSCITATION BECAUSE OF VENTRICULAR FIBRILLATION. OTHER ADVERSE EVENTS INCLUDED: STROKE, TRANSIENT ISCHEMIC ATTACK, AORTIC DISSECTION, MYOCARDIAL INFARCTION, VALVE THROMBOSIS, PROSTHETIC AORTIC VALVE ENDOCARDITIS, NEW ONSET ATRIAL FIBRILLATION, MILD PARAVALVULAR AORTIC REGURGITATION, MAJOR/LIFE-THREATENING BLEEDING, AND REDUCED LEFT VENTRICULAR EJECTION FRACTION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104622 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 Required Intervention