BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 22956845 · Received September 3, 2025

    Report

    Report Number
    2025587-2025-05588
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    May 15, 2024
    Report Date
    September 3, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SANSHUAI CHANG ET AL. PERMANENT PACEMAKER REDUCTION USING TEMPORARY-PERMANENT PACEMAKER AS A 1-MONTH BRIDGE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT: A PROSPECTIVE, MULTICENTRE, SINGLE-ARM, OBSERVATIONAL STUDY. ECLINICALMEDICINE. 2024 MAY 15:72:102603. DOI: 10.1016/J.ECLINM.2024.102603. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING PERMANENT PACEMAKER REDUCTION WITH USE OF TEMPORARY PACEMAKER AS A ONE-MONTH BRIDGE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION INCLUDED 70 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 74.3 YEARS OLD. MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; AN UNDISCLOSED NUMBER OF PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT PRO BIOPROSTHETIC VALVE. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC HEART VALVE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256344 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-23

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R| L