BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 22957866 · Received September 3, 2025

    Report

    Report Number
    2025587-2025-05589
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    June 29, 2025
    Report Date
    September 3, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: REN ET AL. HOW ACCURATE IS INTRAPROCEDURAL TRANSTHORACIC ECHOCARDIOGRAPHY IN ASSESSING AORTIC REGURGITATION AFTER TRANSCATHETHER AORTIC VALVE IMPLANTATION. A SINGLE CENTER EXPERIENCE. INT J CARDIOL. 2025 NOV 1:438:133565. DOI: 10.1016/J.IJCARD.2025.133565. EPUB 2025 JUN 29. 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. 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 INTRAPROCEDURAL TRANSTHORACIC ECHOCARDIOGRAPHY FOR ASSESSMENT OF AORTIC REGURGITATION AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. THE STUDY POPULATION INCLUDED 404 PATIENTS FROM A SINGLE CENTER. MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION AND INCLUDED MEDTRONIC EVOLUT R OR EVOLUT PRO BIOPROSTHETIC VALVES. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: MILD TO MODERATE AORTIC REGURGITATION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293337 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| H