BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10126648 · Received June 7, 2020

    Report

    Report Number
    2025587-2020-01819
    Event Type
    Injury
    Date Received
    June 7, 2020
    Date of Event
    February 7, 2020
    Report Date
    June 7, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: VERHOYE JP ET AL. EARLY OUTCOMES OF TRANSCAROTID ACCESS FOR TRANSCATHETER AORTIC VALVE IMPLANTATION. EUROINTERVENTION. 2020; 15: E1332-1334. DOI: 10.4244/EIJ-D-18-01192. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A RETROSPECTIVE STUDY INTO THE EARLY OUTCOMES OF PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVR) VIA TRANSCAROTID ACCESS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN APRIL 2017 AND JUNE 2018. THE STUDY POPULATION INCLUDED 50 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 71 YEARS), 7 OF WHICH WERE IMPLANTED WITH MEDTRONIC EVOLUT R TRANSCATHETER VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), LIFE-THREATENING BLEEDING, ACUTE KIDNEY INJURY, MINOR VASCULAR ACCESS COMPLICATIONS, PERMANENT PACEMAKER IMPLANTATION, ATRIAL FIBRILLATION, MODERATE AORTIC REGURGITATION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN 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
    590598 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R