BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 11942489 · Received June 4, 2021

    Report

    Report Number
    2025587-2021-01790
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    December 4, 2020
    Report Date
    June 4, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KI Y-J, ET AL. OPTIMAL OVERSIZING INDEX DEPENDING ON VALVE TYPE AND LEAKAGE-PROOF FUNCTION FOR PREVENTING PARAVALVULAR LEAKAGE AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. J CLIN MED. 2020 DEC 4;9(12):3936. DOI: 10.3390/JCM9123936. 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). 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 PATIENT, DEVICE, AND PROCEDURAL FACTORS FOR PREDICTING PARAVALVULAR LEAK (PVL) AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WAS RETROSPECTIVELY COLLECTED AND ANALYZED FROM A SINGLE CENTER REGISTRY BETWEEN JULY 2011 AND FEBRUARY 2020. THE OVERALL STUDY POPULATION INCLUDED 238 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEDIAN AGE OF 78.5 YEARS. MEDTRONIC TRANSCATHETER VALVES WERE IMPLANTED IN 112 PATIENTS: COREVALVE (37), EVOLUT R (56), AND EVOLUT PRO (19). NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL MEDTRONIC TRANSCATHETER VALVE PATIENTS, ADVERSE EVENTS OBSERVED WITHIN ONE MONTH AFTER TAVI INCLUDED: PERMANENT PACEMAKER IMPLANTATION, AND MILD TO MODERATE PVL. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839520 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention