BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 22823177 · Received August 16, 2025

    Report

    Report Number
    2025587-2025-05524
    Event Type
    Injury
    Date Received
    August 16, 2025
    Date of Event
    January 15, 2025
    Report Date
    August 16, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ARTURI ET AL. DECODING HIGH POST-TAVR GRADIENTS: INSIGHTS FROM 4 CLINICAL SCENARIOS. JACC CASE REP. 2025 JAN 15;30(2):102774. DOI: 10.1016/J.JACCAS.2024.102774. 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 FOUR CASES WITH HIGH TRANSVALVULAR GRADIENTS FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION WAS PREDOMINATELY FEMALE WITH A MEAN AGE OF 74.5 YEARS OLD. MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; TWO PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT R AND/OR HANCOCK AORTIC BIOPROSTHETIC VALVE. CASE 1: A 71-YEAR-OLD FEMALE PATIENT PRESENTED WITH SEVERE INTRA-PROSTHETIC AORTIC VALVE REGURGITATION OF A MEDTRONIC 23 MM HANCOCK SURGICAL VALVE WHICH HAD BEEN IMPLANTED 13 YEARS PRIOR. SUBSEQUENTLY, THE PATIENT UNDERWENT A SUCCESSFUL IMPLANT OF A MEDTRONIC 23 MM EVOLUT R TRANSCATHETER VALVE INSIDE THE HANCOCK SURGICAL VALVE. POST-PROCEDURAL ECHOCARDIOGRAPHY REVEALED HIGH MEAN TRANSVALVULAR GRADIENTS OF 26 MMHG. NO FURTHER DETAILS WERE PROVIDED ON THIS CASE. CASE 4: A 70-YEAR-OLD MALE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE DUE TO SEVERE STRUCTURAL VALVE OF A NON-MEDTRONIC TRANSCATHETER VALVE. SUBSEQUENTLY, THE PATIENT UNDERWENT A SUCCESSFUL IMPLANT OF A MEDTRONIC 26 MM EVOLUT R TRANSCATHETER VALVE INSIDE THE NON-MEDTRONIC TRANSCATHETER VALVE. POST-PROCEDURAL ECHOCARDIOGRAPHY REVEALED HIGH MEAN TRANSVALVULAR GRADIENTS OF 22 MMHG AND FLUOROSCOPIC VIEWS SHOWED SUBOPTIMAL VALVE EXPANSION WITH EVIDENT CONSTRICTION OF THE VALVE STENT. IN THIS CASE, NO RING FRACTURE WAS ATTEMPTED. NO FURTHER DETAILS WERE PROVIDED ON THIS CASE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2660705 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-26

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Life Threatening| H