BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 6520662 · Received April 25, 2017

    Report

    Report Number
    2025587-2017-00673
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    September 15, 2016
    Report Date
    May 16, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMPACT OF RENAL DYSFUNCTION ON RESULTS OF TRANSCATHETER AORTIC VALVE REPLACEMENT OUTCOMES IN A LARGE MULTICENTER COHORT CITATION: THE AMERICAN JOURNAL OF CARDIOLOGY (2016) 118(12):1888-189 (DOI 10.1016/J.AMJCARD.2016.08.082) AUTHORS: PABLO CODNER, MD ET AL. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE IMPACT OF RENAL DYSFUNCTION AFTER THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN 2006 AND 2015. THE STUDY POPULATION INCLUDED 1,204 PATIENTS (PREDOMINANTLY MALE), 790 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE AND 4 OF WHICH WERE IMPLANTED WITH AN EVOLUT R TRANSCATHETER BIOPROSTHETIC AORTIC VALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: BLEEDING, VASCULAR COMPLICATIONS, DEVICE FAILURE, PERMANENT PACEMAKER IMPLANT, AND CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN/AUTHOR STATED THAT MEDTRONIC PRODUCTS DID NOT CAUSE OR CONTRIBUTE TO THE OBSERVED DEATHS OR ADVERSE EVENTS, AND ALSO PROVIDED THE MEAN PATIENT AGE (76.1 YEARS) AND WEIGHT (61 KG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301326 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention