BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8656441 · Received May 30, 2019

    Report

    Report Number
    2025587-2019-01751
    Event Type
    Injury
    Date Received
    May 30, 2019
    Date of Event
    March 19, 2018
    Report Date
    May 30, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RIBEIRO HB ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH LOW-FLOW, LOW-GRADIENT AORTIC STENOSIS: THE TOPAS-TAVI REGISTRY. J AM COLL CARDIOL. 2018 MAR 27; 71 (12): 1297-1308. DOI: 10.1016/J.JACC.2018.01.054. EPUB 2018 MAR 19. 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. (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 CLINICAL OUTCOMES AND CHANGES IN LEFT VENTRICULAR EJECTION FRACTION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN PATIENTS WITH CLASSICAL LOW-FLOW, LOW-GRADIENT AORTIC STENOSIS. CLINICAL OUTCOMES WERE DEFINED ACCORDING TO VALVE ACADEMIC RESEARCH CONSORTIUM-2 (VARC-2) CRITERIA. ALL DATA WERE COLLECTED FROM 14 CENTERS BETWEEN 2007 AND 2017. THE STUDY POPULATION INCLUDED 287 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 80 YEARS), 48 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES AND 2 WERE IMPLANTED WITH MEDTRONIC EVOLUT R BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 11 DEATHS OCCURRED WITHIN 30 DAYS POST IMPLANT (5 OF THOSE WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE). THE LATE DEATHS (MEAN FOLLOW-UP OF 21 MONTHS POST IMPLANT) INCLUDED: 112 TOTAL DEATHS (54 OF THOSE WERE DUE TO CARDIOVASCULAR CAUSES). MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTATION, CONVERSION TO OPEN-HEART SURGERY, SECOND VALVE REQUIRED, DISABLING/NON-DISABLING STROKE, MYOCARDIAL INFARCTION, PERIPROCEDURAL HEMODYNAMIC SUPPORT (INTRA-AORTIC BALLOON PUMP OR EXTRACORPOREAL MEMBRANE OXYGENATION), CORONARY OBSTRUCTION, ANNULUS RUPTURE, CARDIAC TAMPONADE, ENDOCARDITIS, MODERATE-SEVERE RESIDUAL AORTIC REGURGITATION, MODERATE-SEVERE MITRAL REGURGITATION, MAJOR VASCULAR COMPLICATIONS, AND MAJOR OR LIFE-THREATENING BLEEDING. 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
    447734 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