BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8210696 · Received January 2, 2019

    Report

    Report Number
    2025587-2019-00033
    Event Type
    Injury
    Date Received
    January 2, 2019
    Date of Event
    September 20, 2018
    Report Date
    January 2, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FINKELSTEIN A ET AL. EFFICACY AND SAFETY OF NEW-GENERATION TRANSCATHETER AORTIC VALVES: INSIGHTS FROM THE ISRAELI TRANSCATHETER AORTIC VALVE REPLACEMENT REGISTRY. CLIN RES CARDIOL. 2018 SEP 20. DOI: 10.1007/S00392-018-1372-6. [EPUB AHEAD OF PRINT] 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 PROCEDURAL OUTCOMES IN PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT WITH NEW-GENERATION VALVES. ALL DATA WERE COLLECTED FROM FOUR CENTERS BETWEEN FEBRUARY 2012 AND DECEMBER 2016. THE STUDY POPULATION INCLUDED 735 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 82 YEARS), 512 OF WHICH WERE IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (23 MM, 26 MM, AND 29 MM PROSTHESIS SIZES WERE USED). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL EVOLUT R PATIENTS, THE PROCEDURAL MORTALITY RATE WAS 1%. THE 1-MONTH, 1-YEAR, AND 3-YEAR ALL-CAUSE MORTALITY RATES FOR EVOLUT R PATIENTS VS. EDWARDS SAPIEN S3 PATIENTS WERE: 1.9% VS. 1.3%, 8% VS. 8.5%, AND 9.7 VS. 10.3%, RESPECTIVELY. BASED ON THE LIMITED AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THESE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, NEED FOR A SECOND VALVE, VALVE-RELATED DYSFUNCTION RE QUIRING REPEAT PROCEDURE, CORONARY ARTERY OBSTRUCTION REQUIRING INTERVENTION, STROKE, VALVE MALPOSITION, CONVERSION TO SURGERY, SEPTAL PERFORATION, MITRAL APPARATUS DAMAGE, TAMPONADE, ANNULAR RUPTURE, PROCEDURAL CARDIOPULMONARY RESUSCITATION, PERI-PROCEDURAL MYOCARDIAL INFARCTION, NEW LEFT BUNDLE BRANCH BLOCK, NEW ATRIAL FIBRILLATION, MODERATE-SEVERE PARAVALVULAR LEAK, LIFE-THREATENING BLEEDING, MAJOR VASCULAR COMPLICATIONS, AND ELEVATED AORTIC VALVE PRESSURE GRADIENTS. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; HOWEVER, BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897 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