BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 7323350 · Received March 8, 2018

    Report

    Report Number
    2025587-2018-00514
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    September 29, 2017
    Report Date
    March 8, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GAEDE L PACEMAKER IMPLANTATION AFTER TAVI: PREDICTORS OF AV BLOCK PERSISTENCE. CLIN RES CARDIOL. 2018 JAN;107(1):60-69. DOI: 10.1007/S00392-017-1158-2. EPUB (B)(6) 2017. 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. 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 PREDICTORS OF ATRIOVENTRICULAR BLOCK (AV) PERSISTENCE WITH CONCURRENT PERMANENT PACEMAKER DEPENDENCY AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2010 AND 2015. THE STUDY POPULATION INCLUDED 1,025 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 82 YEARS), 245 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE DEVICE AND 2 PATIENTS WERE IMPLANTED WITH COREVALVE EVOLUT DEVICE. THE SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CONDUCTION DISTURBANCES- SINOATRIAL (SA) BLOCK, ATRIO- VENTRICULAR (AV) BLOCK FIRST, SECOND AND THIRD DEGREE, BRADYCARDIA AND PERMANENT PACEMAKER IMPLANTATION. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY BE ATTRIBUTED TO MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168524 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention