BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 10015293 · Received April 30, 2020

    Report

    Report Number
    2025587-2020-01526
    Event Type
    Injury
    Date Received
    April 30, 2020
    Date of Event
    November 21, 2019
    Report Date
    April 30, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KOO HJ ET AL. COMPUTED TOMOGRAPHY FEATURES OF CUSPAL THROMBOSIS AND SUBVALVULAR TISSUE INGROWTH AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. AM J CARDIOL. 2020 FEB 15;125(4):597-606. DOI: 10.1016/J.AMJCARD.2019.11.015. EPUB 2019 NOV 21. 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 THE 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 AN EVALUATION OF COMPUTED TOMOGRAPHY SCANS OF PATIENTS FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) AND AN INVESTIGATION OF THE FACTORS ASSOCIATED WITH HYPOATTENUATING LEAFLET THICKENING. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN MARCH 2011 AND DECEMBER 2017. THE STUDY POPULATION INCLUDED 395 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 78 YEARS. OF THOSE, 134 WERE IMPLANTED WITH MEDTRONIC TRANSCATHETER VALVES: COREVALVE (85) AND EVOLUT R (49). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 54 DEATHS OCCURRED. MEDTRONIC AND NON-MEDTRONIC TRANSCATHETER VALVES WERE USED IN THE STUDY AND NO FURTHER DETAILS ABOUT THE DEATHS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. THE MEDIAN DURATION FROM TAVI TO THE LAST ECHOCARDIOGRAPHIC FOLLOW-UP AND CARDIAC COMPUTED TOMOGRAPHY IMAGING WAS 364 DAYS AND 17.5 DAYS, RESPECTIVELY. ADVERSE EVENTS INCLUDED: TRANSCATHETER VALVE-IN-VALVE IMPLANTATION DUE TO HYPOATTENUATING SUBVALVULAR THICKENING WITH SEVERE LEAFLET MOTION LIMITATION AND HIGH PEAK VELOCITY/PRESSURE GRADIENTS; PERMANENT PACEMAKER IMPLANTATION; MILD-MODERATE-SEVERE PARAVALVULAR LEAK; HYPOATTENUATING LEAFLET THICKENING; THROMBUS WITHIN THE SINUS OF VALSALVA (OBSERVED IN 4 COREVALVE PATIENTS AND 0 EVOLUT R PATIENTS); LIMITED LEAFLET MOTION; SUPRAVALVULAR THICKENING; AND HIGH PEAK VELOCITY/PRESSURE GRADIENTS. 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
    478529 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention