BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 14162236 · Received April 20, 2022

    Report

    Report Number
    2025587-2022-01031
    Event Type
    Death
    Date Received
    April 20, 2022
    Date of Event
    November 10, 2021
    Report Date
    April 20, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KOSEKI K.; ET AL. IMPACT OF PULMONARY ARTERY DILATATION ON CLINICAL OUTCOMES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC CARDIOVASC INTERV. 2021 DEC 13;14(23):2560-2569. DOI: 10.1016/J.JCIN.2021.08.023. PMID: 34774478. EPUB 2021 NOV 10 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. MEDTRONIC PRODUCTS REFERENCED: EVOLUT R, EVOLUT PRO (PMA# P130021, PRODUCT CODE: NPT). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING THE MORTALITY IMPACT OF PULMONARY ARTERY DILATATION/PULMONARY HYPERTENSION ON PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN (B)(6) 2013 AND (B)(6) 2017. THE STUDY POPULATION INCLUDED 895 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 81 YEARS), 109 OF WHOM WERE IMPLANTED WITH MEDTRONIC EVOLUT R BIOPROSTHETIC VALVES AND 14 WITH EVOLUT PRO BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). PATIENTS UNDERWENT PRE-PROCEDURAL AND POST-PROCEDURAL CHEST COMPUTERIZED TOMOGRAPHY (CT) AND TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) TO EVALUATE PULMONARY ARTERY DIMENSIONS, TRANSVALVULAR PRESSURES AND TAVR VALVE FUNCTION. AMONG ALL PATIENTS, 2-YEAR ALL-CAUSE MORTALITY WAS 11.4% OF THE STUDY POPULATION, HOWEVER THE CAUSES OF DEATH AND FURTHER DETAILS WERE NOT PROVIDED. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THESE MORTALITY STATISTICS. ONE DEATH OCCURRED DURING THE TAVR PROCEDURE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THIS DEATH. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: CORONARY OBSTRUCTION AND AORTIC ROOT INJURIES AFTER TAVR, NEED FOR NEW PERMANENT PACEMAKER IMPLANTATION, MODERATE-SEVERE PARAVALVULAR LEAKS (PVL), MYOCARDIAL INFARCTIONS, STROKES, MAJOR BLEEDING/VASCULAR COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN 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
    1272695 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death