BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 11902200 · Received May 28, 2021

    Report

    Report Number
    2025587-2021-01733
    Event Type
    Injury
    Date Received
    May 28, 2021
    Date of Event
    April 3, 2020
    Report Date
    May 28, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GORLA R, ET AL. TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE PORTICO AND EVOLUT R BIOPROSTHESES IN PATIENTS WITH ELLIPTIC AORTIC ANNULUS. EUROINTERVENTION. 2020 APR 3;15(18):E1588-E1591. DOI: 10.4244/EIJ-D-19-00115. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. 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 COMPARISON OF PARAVALVULAR LEAK (PVL) AND DEVICE SUCCESS RATES FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING THE PORTICO AND EVOLUT R IN PATIENTS WITH AN ELLIPTIC AORTIC ANNULUS. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER. THE STUDY POPULATION INCLUDED 374 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 83.6 YEARS. OF THOSE, 263 PATIENTS UNDERWENT TAVI WITH THE MEDTRONIC EVOLUT R. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL EVOLUT R PATIENTS, 13 DEATHS OCCURRED WITHIN THIRTY DAYS OF TAVI. THE CIRCUMSTANCES OF THE DEATHS WERE NOT DISCLOSED, AND NO CORRELATION WAS MADE BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL EVOLUT R PATIENTS, ADVERSE EVENTS INCLUDED: NEED FOR IMPLANTATION OF A SECOND VALVE; EMERGENT CARDIAC SURGERY; PERMANENT PACEMAKER IMPLANTATION; MILD TO SEVERE PVL; AND UNSPECIFIED VASCULAR COMPLICATIONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797641 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention