BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8436428 · Received March 20, 2019

    Report

    Report Number
    2025587-2019-00985
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    September 13, 2018
    Report Date
    March 20, 2019
    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: HUDZIAK, D. ET AL. PROSPECTIVE REGISTRY ON CEREBRAL OXIMETRY-GUIDED TRANSCAROTID TAVI IN PATIENTS WITH MODERATE-HIGH RISK AORTIC STENOSIS. MINERVA CARDIOANGIOLOGICA. 2019; 67(1):11-8. DOI: 10.23736/S0026-4725.18.04799-0 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 OUTCOMES AFTER OXIMETRY GUIDED TRANSCAROTID TRANSCATHETER AORTIC VALVE IMPLANT IN PATIENTS WITH MODERATE-HIGH RISK AORTIC STENOSIS. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN SEPTEMBER 2017 AND MAY 2018. THE STUDY POPULATION INCLUDED 10 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 80.6 YEARS), NINE OF WHICH WERE IMPLANTED WITH A MEDTRONIC EVOLUTR VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: TRIVIAL/MILD PARAVALVULAR LEAK (PVL), WHICH WAS FURTHER REDUCED UPON THREE-MONTH FOLLOW UP, TEMPORARY HEART BLOCK AND PERMANENT PACEMAKER IMPLANT. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230429 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention