BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 11653952 · Received April 12, 2021

    Report

    Report Number
    2025587-2021-01121
    Event Type
    Injury
    Date Received
    April 12, 2021
    Date of Event
    October 2, 2020
    Report Date
    April 12, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: QUINE EJ ET AL. LONG-TERM OUTCOMES STRATIFIED BY BODY MASS INDEX IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. AMERICAN JOURNAL OF CARDIOLOGY. 2020; 137:77-82. DOI: 10.1016/J.AMJCARD.2020.09.039 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUTR (PMA# P130021, PRODUCT CODE NPT), EVOLUTPRO (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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING AN ANALYSIS INTO THE DEPENDENCE OF BODY MASS INDEX (BMI) ON THE OUTCOMES OF PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) FOR SEVERE, SYMPTOMATIC AORTIC STENOSIS. ALL DATA WERE COLLECTED FROM TWO CENTERS BETWEEN AUGUST 2008 AND APRIL 2019. THE STUDY POPULATION INCLUDED 634 PATIENTS (PREDOMINANTLY MALE, PREDOMINANTLY CAUCASIAN, MEAN AGE 82.7 YEARS), 160, 261, AND 23 OF WHOM WERE IMPLANTED WITH A MEDTRONIC COREVALVE, EVOLUT R, AND EVOLUT PRO TRANSCATHETER VALVE, RESPECTIVELY (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 8, 26, AND 48 DEATHS OCCURRED WITHIN 30 DAYS, 1 YEAR, AND 2 YEARS POST VALVE IMPLANT, RESPECTIVELY. NO FURTHER DETAILS WERE PROVIDED ABOUT THE DEATHS, AND NO ASSOCIATION WAS MADE BETWEEN THE TRANSCATHETER VALVES AND THE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKE, MYOCARDIAL INFARCTION, MAJOR BLEEDING, VASCULAR ACCESS COMPLICATIONS, PERMANENT PACEMAKER IMPLANTATION, MODERATE-SEVERE PARAVALVULAR LEAK. 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
    550392 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R