BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 13506690 · Received February 10, 2022

    Report

    Report Number
    2025587-2022-00414
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    October 19, 2021
    Report Date
    February 10, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KURE Y, ET AL. KIHON CHECKLIST IS USEFUL FOR PREDICTING OUTCOMES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. J CARDIOL. 2022 FEB;79(2):299-305. DOI: 10.1016/J.JJCC.2021.09.014. EPUB 2021 OCT 19. 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), EVOLUT PRO (PMA# P130021, PRODUCT CODE NPT), 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 FROM A LITERATURE ARTICLE REGARDING THE PROGNOSTIC IMPACT OF FRAILTY EVALUATED BY THE KIHON CHECKLIST IN TRANSCATHETER AORTIC VALVE IMPLANTATION PATIENTS. ALL DATA WAS COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2016 AND DECEMBER 2020. OF THE 280 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY FEMALE, MEDIAN AGE 84 YEARS), 77 WERE IMPLANTED WITH A MEDTRONIC TRANSCATHETER VALVE: COREVALVE (3), EVOLUT R (35), OR EVOLUT PRO/PRO+ (39). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. OF THE 280 PATIENTS IN THE STUDY POPULATION, 4 CARDIOVASCULAR AND 46 NON-CARDIOVASCULAR DEATHS OCCURRED, RESPECTIVELY. NO STATEMENT WAS MADE SUGGESTING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. ADVERSE EVENTS (PERI- AND POST-PROCEDURAL COMPLICATIONS) INCLUDED: CORONARY OCCLUSION, PERMANENT PACEMAKER IMPLANTATION, DISABLING STROKE, MODERATE TO SEVERE AORTIC REGURGITATION, BLEEDING (CLASSIFIED AS ALL OR LIFE-THREATENING/MAJOR), VASCULAR COMPLICATIONS, AND CARDIAC TAMPONADE. MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845195 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention| S| L