BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 9435051 · Received December 8, 2019

    Report

    Report Number
    2025587-2019-03694
    Event Type
    Injury
    Date Received
    December 8, 2019
    Date of Event
    October 1, 2019
    Report Date
    December 8, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SOTIRIS C. ET AL. EARLY EXPERIENCE WITH EMBOLIC PROTECTION DEVICES DURING TRANSCATHETER AORTIC VALVE REPLACEMENT. JOURNAL OF INVASIVE CARDIOLOGY (2019) 31(10):296-299. 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 RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. ADDITIONAL PATIENT CODES: (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 REGARDING EMBOLIC PROTECTION DEVICES DURING TRANSCATHETER AORTIC VALVE (TAV) REPLACEMENT. ALL DATA WERE COLLECTED FROM A RETROSPECTIVE SINGLE CENTER STUDY BETWEEN OCTOBER 2018 AND FEBRUARY 2019. THE STUDY POPULATION INCLUDED 83 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 85 YEARS). SIXTY-THREE PATIENTS WERE IMPLANTED WITH A NON-MEDTRONIC BALLOON EXPANDABLE TAV AND TWENTY WERE IMPLANTED WITH A MEDTRONIC EVOLUTR TAV. SIX VALVES WERE IMPLANTED VALVE-IN-VALVE INTO A PREVIOUSLY IMPLANTED BIOPROSTHETIC VALVE. THE MANUFACTURERS OF THE PREVIOUSLY IMPLANTED VALVES WERE NOT PROVIDED. NO SERIAL NUMBERS PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: CEREBRAL VASCULAR ACCIDENT (CVA), CARDIAC ARREST, PERMANENT PACEMAKER, VASCULAR COMPLICATIONS AND THE NEED FOR HEMODIALYSIS. BASED ON THE AVAILABLE INFORMATION, A MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT(S). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229821 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention