BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 12021955 · Received June 17, 2021

    Report

    Report Number
    2025587-2021-01935
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    March 1, 2021
    Report Date
    June 17, 2021
    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: LEE YJ ET AL. COMPARISON OF TRANSCATHETER AORTIC VALVE REPLACEMENT BETWEEN SELF-EXPANDING VERSUS BALLOON-EXPANDABLE VALVES IN PATIENTS WITH SMALL AORTIC ANNULUS. KOREAN CIRCULATION JOURNAL. 2021; 51(3):222-231. DOI: 10.4070/KCJ.2020.0409 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R (PMA# P130021, PRODUCT CODE NPT), EVOLUT PRO (PMA# P130021, PRODUCT CODE NPT). EARLIEST APPROVED PRODUCT USED PMA#. 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. 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 A COMPARATIVE ANALYSIS INTO THE OUTCOMES OF PATIENTS WITH SEVERE AORTIC STENOSIS AND A SMALL AORTIC ANNULUS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH EITHER A SELF-EXPANDING OR BALLOON-EXPANDABLE TRANSCATHETER VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN (B)(6) 2016 AND (B)(6) 2020. THE STUDY POPULATION INCLUDED 70 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 81.7 YEARS, MEAN WEIGHT 54.5 KG), 37 OF WHOM WERE IMPLANTED WITH A MEDTRONIC EVOLUT R TRANSCATHETER VALVE AND 8 OF WHOM WERE IMPLANTED WITH A MEDTRONIC EVOLUT PRO TRANSCATHETER VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL MEDTRONIC EVOLUT R AND EVOLUT PRO PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, PERCUTANEOUS CORONARY INTERVENTION, ACUTE KIDNEY INJURY, MAJOR BLEEDING, MAJOR VASCULAR COMPLICATIONS, MYOCARDIAL INFARCTION, HEART FAILURE, SECOND VALVE IMPLANTATION, MODERATE PATIENT-PROSTHESIS MISMATCH, MODERATE PARAVALVULAR LEAK. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    911368 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R