BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9558941 · Received January 7, 2020

    Report

    Report Number
    2025587-2020-00054
    Event Type
    Injury
    Date Received
    January 7, 2020
    Date of Event
    July 1, 2019
    Report Date
    January 7, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: STORTECKY S ET AL. TEMPORAL TRENDS IN ADOPTION AND OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION: A SWISS TAVI REGISTRY ANALYSIS. EUR HEART J QUAL CARE CLIN OUTCOMES. 2019 JUL 1;5(3):242-251. DOI: 10.1093/EHJQCCO/QCY048. 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 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 PROGRESSIVE TRENDS IN ADOPTION AND PERFORMANCE OF TRANSCATHETER AORTIC VALVE IMPLANTATION IN (B)(6) OVER A FIVE-YEAR PERIOD. ALL DATA WERE COLLECTED FROM 14 CENTERS BETWEEN 2011 AND 2015. THE STUDY POPULATION INCLUDED 3,493 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 82 YEARS. OF THOSE, 1,248 WERE IMPLANTED WITH MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVES: COREVALVE (914) AND EVOLUT R (334). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, THE OVERALL ONE-YEAR ALL-CAUSE AND CARDIAC MORTALITY RATES WERE 12.8% (437 PATIENTS) AND 8.9% (301 PATIENTS), RESPECTIVELY. NO OTHER DETAILS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, UNPLANNED REPEAT INTERVENTIONS, VALVE-IN-VALVE IMPLAN TATION, SURGICAL REVISION, PROCEDURAL COMPLICATIONS THAT REQUIRED CONVERSION TO SURGERY, DISABLING STROKE, NON-DISABLING STROKE, TRANSIENT ISCHEMIC ATTACK, PERI-PROCEDURAL OR SPONTANEOUS MYOCARDIAL INFARCTION, MODERATE-SEVERE PARAVALVULAR LEAK, LIFE-THREATENING OR MAJOR BLEEDING, AND MINOR/MAJOR VASCULAR ACCESS SITE COMPLICATIONS. NO TREATMENT OR INTERVENTION WAS REPORTED AS A RESULT OF THE OBSERVED MINOR/MAJOR VASCULAR ACCESS SITE COMPLICATIONS. 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
    20223 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