BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 12285185 · Received August 5, 2021

    Report

    Report Number
    2025587-2021-02473
    Event Type
    Injury
    Date Received
    August 5, 2021
    Date of Event
    August 29, 2020
    Report Date
    August 5, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: TAMM AR, ET AL. LONG-TERM OUTCOME WITH NEW GENERATION PROSTHESES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACE MENT. J CLIN MED. 2021 JUL; 10(14): 3102. PUBLISHED ONLINE 2021 JUL 14. DOI: 10.3390/JCM10143102. PRESENTED AT THE ESC CONGRESS 2020 ¿ THE DIGITAL EXPERIENCE 29 AUGUST ¿ 1 SEPTEMBER 2020. EARLIEST DATE OF PRESENTATION 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 THE PATIENT OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH NEW GENERATION VALVES. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JUNE 2014 AND MAY 2016. OF THE 359 PATIENTS INCLUDED IN THE STUDY POPULATION, 144 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 82.2 YEARS) UNDERWENT TAVR WITH THE MEDTRONIC EVOLUT R. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. IN THE EVOLUT R GROUP, THREE DEATHS OCCURRED WITHIN THIRTY DAYS OF TAVR AND A MEAN SURVIVAL OF 3.3 YEARS WAS OBSERVED DURING LONG-TERM FOLLOW-UP. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN EVOLUT R AND THE DEATHS. IN THE EVOLUT R GROUP, NON-DEATH ADVERSE EVENTS INCLUDED: CONVERSION TO OPEN HEART SURGERY (1 CASE); STROKE (2 CASES); NEW PERMANENT PACEMAKER IMPLANTATION (57 CASES); PARAVALVULAR REGURGITATION/LEAK = GRADE 2 (5 CASES); LIFE-THREATENING OR DISABLING BLEEDING (2 CASES); AND MAJOR VASCULAR COMPLICATIONS (7 CASES). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176737 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening| R| S