BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 11690654 · Received April 19, 2021

    Report

    Report Number
    2025587-2021-01191
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    October 28, 2020
    Report Date
    April 19, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KAWASHIMA H, ET AL. DIRECT ORAL ANTICOAGULANTS VERSUS VITAMIN K ANTAGONISTS IN PATIENTS WITH ATRIAL FIBRILLATION AFTER TAVR. JACC CARDIOVASC INTERV. 2020 NOV 23;13(22):2587-2597. DOI: 10.1016/J.JCIN.2020.09.013. EPUB 2020 OCT 28. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: COREVALVE (PMA# P130021, PRODUCT CODE NPT), EVOLUT R (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 FROM A LITERATURE ARTICLE REGARDING THE LONG-TERM ALL-CAUSE MORTALITY OF PATIENTS WITH CHRONIC OR NEW ATRIAL FIBRILLATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WHO WERE PRESCRIBED DIRECT ORAL ANTICOAGULANTS (DOACS) OR VITAMIN K ANTAGONISTS (VKAS). ALL DATA WAS COLLECTED FROM A FOURTEEN-CENTER REGISTRY BETWEEN OCTOBER 2013 AND MAY 2017. THE STUDY POPULATION INCLUDED 403 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 84 YEARS. OF THOSE, 62 PATIENTS WERE IMPLANTED WITH MEDTRONIC TRANSCATHETER VALVES: COREVALVE (36) OR EVOLUT R (26). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL 403 PATIENTS, THE ALL-CAUSE MORTALITY RATES DURING THE MEDIAN FOLLOW-UP OF 568 DAYS (RANGE OF 367 TO 819 DAYS) WERE 10.3% FOR DOAC PATIENTS AND 23.3% FOR VKA PATIENTS, RESPECTIVELY. EDWARDS SAPIEN TRANSCATHETER VALVES WERE ALSO IMPLANTED IN THE STUDY POPULATION. NONE OF THE DEATHS WERE DIRECTLY ASSOCIATED WITH MEDTRONIC PRODUCT. AMONG ALL 403 PATIENTS, ADVERSE EVENTS INCLUDED: ALL BLEEDING, LIFE-THREATENING OR MAJOR BLEEDING, MINOR BLEEDING, GASTROINTESTINAL BLEEDING, HEMORRHAGIC STROKE, ISCHEMIC STROKE, AND NEW ONSET ATRIAL FIBRILLATION. 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
    586839 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening