BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10103246 · Received May 29, 2020

    Report

    Report Number
    2025587-2020-01748
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    March 4, 2020
    Report Date
    May 29, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HAMILTON GW ET AL. META-ANALYSIS COMPARING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION WITH SELF-EXPANDING VERSUS BALLOON-EXPANDABLE VALVES. AM J CARDIOL. 2020 MAY 15;125(10):1558-1565. DOI: 10.1016/J.AMJCARD.2020.02.021. EPUB 2020 MAR 4. 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 THROUGH A LITERATURE ARTICLE REGARDING A COMPARISON OF THE PATIENT OUTCOMES BETWEEN SELF-EXPANDING AND BALLOON-EXPANDABLE TRANSCATHETER HEART VALVES FOLLOWING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION (VIV TAVI) IN DETERIORATED SURGICAL VALVES. ALL DATA WERE COLLECTED FROM A META-ANALYSIS REVIEW OF NINETEEN STUDIES PUBLISHED BETWEEN 2011 AND 2019. THE STUDY POPULATION INCLUDED 1,772 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 77 YEARS. OF THOSE, 22 PREVIOUSLY UNDERWENT SURGICAL AORTIC VALVE REPLACEMENT (SAVR) WITH MEDTRONIC FREESTYLE STENTLESS VALVES AND 924 UNDERWENT VIV TAVI WITH MEDTRONIC COREVALVE, EVOLUT R, OR EVOLUT PRO SELF-EXPANDING TRANSCATHETER VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL COREVALVE, EVOLUT R, AND EVOLUT PRO PATIENTS, THE 30-DAY, 12-MONTH, AND 3-YEAR MORTALITY RATES WERE 4.1%, 10.3%, AND 21.2%, RESPECTIVELY. NO FURTHER DETAILS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL FREESTYLE PATIENTS, ADVERSE EVENTS INCLUDED: VIV TAVI DUE TO AORTIC REGURGITATION, AORTIC STENOSIS, OR A COMBINATION OF BOTH AT A MEAN 12 YEARS AFTER SAVR. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL COREVALVE, EVOLUT R, AND EVOLUT PRO PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION, UNSPECIFIED NEED FOR URGENT CARDIAC SURGERY, SECOND TRANSCATHETER VALVE IMPLANTED DURING THE INDEX PROCEDURE FOR AN UNKNOWN REASON, STROKE, CORONARYOBSTRUCTION, BLEEDING, VASCULAR COMPLICATIONS, MODERATE-SEVERE PARAVALVULAR LEAK, AND TRANSVALVULAR MEAN GRADIENT GREATER THAN OR EQUAL TO 20 MMHG. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS 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
    564331 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention