BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 14162728 · Received April 20, 2022

    Report

    Report Number
    2025587-2022-01034
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 20, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KOCKA ET AL. NURSE-LED SEDATION FOR TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION SEEMS SAFE FOR A SELECTED PATIENT POPULATION. EUR HEART J SUPPL. (B)(6) 2022; 24 (SUPPL B): B23-B27. DOI: 10.1093/EURHEARTJSUPP/SUAC004. ECOLLECTION 2022 APR. 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING SEDATION FOR TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN NOVEMBER 1, 2019 AND APRIL 30, 2021. THE STUDY POPULATION INCLUDED 128 PATIENTS (PREDOMINANTLY MALE, MEAN WEIGHT 81.85 KG, MEAN AGE NOT PROVIDED). ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS TWO DEATHS OCCURRED WITHIN 30 DAYS DUE TO A ¿PERI-TAVI STROKE.¿ NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE DEATH(S). AMONG ALL PATIENTS, VALVE-RELATED ADVERSE EVENTS INCLUDED: MODERATE OR SEVERE PARAVALVULAR LEAK (PVL), HYPOTENSION, COMPLETE HEART BLOCK OR OTHER ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, STROKE. DELIVERY CATHETER SYSTEM (DCS)-RELATED EVENTS INCLUDED MAJOR BLEEDING AT THE ACCESS-SITE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265372 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| H| R