BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8238298 · Received January 10, 2019

    Report

    Report Number
    2025587-2019-00154
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 4, 2018
    Report Date
    January 10, 2019
    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

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: VEULEMANS, V. ET AL. COST-COMPARISON OF THIRD GENERATION TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) DEVICES IN THE GERMAN HEALTH CARE SYSTEM. INTERNATIONAL JOURNAL OF CARDIOLOGY. 2018 DEC 4. PII: S0167-5273(18)33582-4. DOI 10.1016/J.IJCARD.2018.12.007 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. (B)(4). 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 COST-COMPARISON OF THIRD GENERATION TRANSCATHETER BIOPROSTHETIC AORTIC VALVES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2014 AND SEPTEMBER 2016. THE STUDY POPULATION INCLUDED 204 PATIENTS, 101 OF WHICH WERE IMPLANTED WITH AN EVOLUTR TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. THE REMAINING PATIENTS WERE IMPLANTED WITH A NON-MEDTRONIC BALLOON-EXPANDABLE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE. PATIENT AGE WAS NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: VASCULAR COMPLICATIONS TREATED WITH A STENT PLACEMENT OR BLOOD TRANSFUSION, PERMANENT PACEMAKER IMPLANT, AORTIC INSUFFICIENCY TREATED WITH A VALVE-IN-VALVE IMPLANT, MYOCARDIAL INFARCTION (MI), ATRIAL FIBRILLATION (AFIB), AND POSITIONING DIFFICULTIES THAT REQUIRED THE USE OF A SNARE. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25626 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention