BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SURGICAL TISSUE VALVE

    MDR report key: 11823322 · Received May 13, 2021

    Report

    Report Number
    2025587-2021-01538
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    December 14, 2020
    Report Date
    May 13, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WITBERG G ET AL. TRANSCATHETER TREATMENT OF RESIDUAL SIGNIFICANT MITRAL REGURGITATION FOLLOWING TAVR. JACC: CARDIOVASCULAR INTERVENTIONS. 2020; 13(23):2782-2791. DOI: 10.1016/J.JCIN.2020.07.014 EARLIEST DATE OF PUBLISH USED FOR EVENT DATE IN B3. MEDTRONIC PRODUCTS REFERENCED: FREESTYLE (PMA# P970031, PRODUCT CODE LWR), HANCOCK II (PMA# P980043, PRODUCT CODE DYE), MOSAIC (PMA# P990064, PRODUCT CODE DYE). EARLIEST APPROVED PRODUCT USED FOR D2 PRODUCT CODE AND G3 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 RETROSPECTIVE ANALYSIS INTO THE PERIPROCEDURAL AND MID-TERM OUTCOMES OF PATIENTS UNDERGOING TRANSCATHETER MITRAL VALVE INTERVENTIONS FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM AN INTERNATIONAL REGISTRY OF 23 CENTERS, BETWEEN 2008 AND JUNE 2019. THE STUDY POPULATION INCLUDED 106 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 79.5 YEARS, MEAN WEIGHT 74.8 KG), 1 OF WHOM WAS IMPLANTED WITH A MEDTRONIC FREESTYLE BIOPROSTHETIC AORTIC VALVE, 2 OF WHOM WERE IMPLANTED WITH A MEDTRONIC HANCOCK II BIOPROSTHETIC MITRAL VALVE, AND 1 OF WHOM WAS IMPLANTED WITH A MEDTRONIC MOSAIC BIOPROSTHETIC MITRAL VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 4 IN-HOSPITAL DEATHS OCCURRED, 1 OF WHICH WAS REPORTED TO BE DUE TO A BLEEDING COMPLICATION. DURING THE FOLLOW-UP PERIOD, 33 DEATHS (12 CARDIAC AND 21 NON-CARDIAC) WERE REPORTED; 1 OF WHICH WAS REPORTED TO BE DUE TO SEPSIS. NO ASSOCIATION WAS MADE BETWEEN THE HEART VALVE PRODUCTS AND THE DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC COREVALVE, EVOLUT R, AND EVOLUT PRO PATIENTS, ADVERSE EVENTS INCLUDED: TRANSCATHETER VALVE-IN-VALVE REPLACEMENT DUE TO UNKNOWN REASONS, MAJOR BLEEDING, CONGESTIVE HEART FAILURE. 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
    712747 MEDTRONIC SURGICAL TISSUE VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION MDT-TISSUE VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R