BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 13285189 · Received January 18, 2022

    Report

    Report Number
    2025587-2022-00125
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    May 14, 2021
    Report Date
    January 18, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: BREITBART P, ET AL. IMPLANTATION DEPTH AND ITS INFUENCE ON COMPLICATIONS AFTER TAVI WITH SELF EXPANDING VALVES. INT J CARDIOVASC IMAGING. 2021 OCT;37(10):3081-3092. DOI: 10.1007/S10554-021-02275-3. EPUB 2021 MAY 14. 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 FROM A LITERATURE ARTICLE REGARDING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) DEPTH AND ITS INFLUENCE ON THE OCCURRENCE OF CONDUCTION DISTURBANCES AND PARAVALVULAR LEAK USING SELF-EXPANDING VALVES. ALL DATA WAS COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2015 AND JUNE 2020. THE STUDY POPULATION INCLUDED 104 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 82.2 YEARS). ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT R TRANSCATHETER VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. ADVERSE EVENTS INCLUDED: VALVE DISLOCATION NECESSITATING SURGICAL REVISION, NEW PERMANENT PACEMAKER IMPLANTATION, NEW CONDUCTION DIS TURBANCES (FIRST-, SECOND-, OR THIRD-DEGREE ATRIOVENTRICULAR BLOCK; LEFT BUNDLE BRANCH BLOCK; SINUATRIAL BLOCK), AND PARAVALVULAR LEAK (MILD TO MODERATE). THE AUTHORS WROTE, ¿IN PATIENTS WITH TAVI USING THE EVOLUT R DEVICE A LOWER TRANSCATHETER HEART VALVE (THV) POSITIONING IS A PREDICTOR FOR NEW CONDUCTION DISTURBANCES. HOWEVER, WE COULD NOT IDENTIFY ANY FACTORS THAT PREDISPOSE TO LOW POSITIONING.¿ NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988046 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 Female Required Intervention