BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 11934969 · Received June 3, 2021

    Report

    Report Number
    2025587-2021-01774
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    February 1, 2021
    Report Date
    June 3, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WIKTOROWICZ A, ET AL. PARAVALVULAR LEAK PREDICTION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT WITH SELF-EXPANDABLE PROSTHESIS BASED ON QUANTITATIVE AORTIC CALCIFICATION ANALYSIS. QUANT IMAGING MED SURG. 2021 FEB;11(2):652-664. DOI: 10.21037/QIMS-20-669. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT: FEBRUARY 1, 2021 (MONTH AND YEAR VALID). 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING A METHOD TO IDENTIFY IMAGING BIOMARKERS TO PREDICT PARAVALVULAR LEAK (PVL) OCCURRENCE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL CLINICAL AND IMAGING DATA WERE COLLECTED AND ANALYZED RETROSPECTIVELY. THE STUDY POPULATION INCLUDED 50 PATIENTS WITH SEVERE AORTIC STENOSIS (TRICUSPID AORTIC VALVE, AORTIC VALVE AREA ¿1.0 CM², MEAN PRESSURE GRADIENT 40 MMHG) WHO ALL UNDERWENT TAVR WITH THE MEDTRONIC EVOLUT R (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). PATIENT DEMOGRAPHICS WERE AS FOLLOWS: PREDOMINANTLY FEMALE WITH A MEDIAN AGE OF 83 YEARS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: BALLOON POST-DILATION PERFORMED DURING THE TAVR PROCEDURE FOR MODERATE TO SEVERE PVL OR VALVE UNDER-EXPANSION; PERMANENT PACEMAKER IMPLANTATION WITHIN ONE YEAR OF TAVR PROCEDURE; AND MILD TO SEVERE PVL THAT OCCURRED DURING LONG-TERM FOLLOW-UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823956 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention