BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVEO R DELIVERY SYSTEM

    MDR report key: 7720388 · Received July 25, 2018

    Report

    Report Number
    2025587-2018-01867
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    June 25, 2018
    Report Date
    October 2, 2018
    Manufacturer
    HEART VALVES SANTA ANA
    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: D'ANCONA G TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE 34 MM MEDTRONIC EVOLUT VALVE : EARLY RESULTS OF SINGLE INSTITUTION EXPERIENCE. NETH HEART J. 2018 AUG;26(7-8):401-408. DOI: 10.1007/S12471-018-1122-4. 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.

    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 REGARDING TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE 34 MM MEDTRONIC EVOLUT VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN FEBRUARY 2017 TO JULY 2017. THE STUDY POPULATION INCLUDED 73 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 81 YEARS), ALL OF THEM WERE IMPLANTED WITH 34MM MEDTRONIC EVOLUT R BIOPROSTHESIS. THE SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: RE-SHEATHING AND RE-POSITIONING, PERMANENT PACEMAKER IMPLANTATION, SURGICAL REPAIR OF FEMORAL ARTERY AND MILD PARAVALVULAR LEAK (PVL). BASED ON THE AVAILABLE INFORMATION, A DIRECT CORRELATION WAS LIKELY BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559845 ENVEO R DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA ENVEOR-L

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention