BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS VALVE

    MDR report key: 19238752 · Received May 3, 2024

    Report

    Report Number
    2025587-2024-02763
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    August 1, 2023
    Report Date
    May 3, 2024
    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: IMAMURA T, IZUMIDA T, ONODA H, ET AL. PROGNOSTIC IMPACT OF REMOTE DIELECTRIC SENSING VALUE FOLLOWING TAVR. HEART VESSELS. 2023;38(12):1468-1475. DOI:10.1007/S00380-023-02294-1. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING THE USE OF REMOTE DIELECTRIC SENSING IN PATIENTS FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). MEDTRONIC EVOLUT PRO+ (N = 16) AND NON-MEDTRONIC SAPIEN 3 (N = 26) VALVE TYPES WERE IMPLANTED IN THE STUDY POPULATION OF 42 PATIENTS. THE AUTHORS OBSERVED THREE DEATHS WITHIN ONE YEAR OF TAVR. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT AN EVOLUT PRO+ VALVE OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. OTHER POST-PROCEDURAL ADVERSE EVENTS INCLUDED: SYSTEMIC INFECTION, NEW ATRIAL FIBRILLATION, NEW COMPLETE LEFT BUNDLE BRANCH BLOCK, PACEMAKER IMPLANTATION, AND HOSPITAL READMISSIONS. REASONS FOR READMISSION CONSISTED OF ILEUS, LIMB ISCHEMIA, FALLING, HEART FAILURE, AND PNEUMONIA. NO ADDITIONAL ADVERSE OUTCOMES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278718 EVOLUT PRO PLUS VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVPROPLUS-23US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R