BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 22538052 · Received July 17, 2025

    Report

    Report Number
    2025587-2025-05114
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    May 8, 2025
    Report Date
    July 17, 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
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GUTHOFF ET AL. CLINICAL IMPACT OF BALLOON-EXPANDABLE VS SELF-EXPANDING TAVR IN SMALL AORTIC ANNULI. JACC CARDIOVASC INTERV. 2025 JUN 23;18(12):1611-1613. DOI: 10.1016/J.JCIN.2025.03.020. 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 THE CLINICAL IMPACT OF BALLOON-EXPANDABLE VERSUS SELF-EXPANDING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN PATIENTS WITH SMALL AORTIC ANNULI. THE STUDY POPULATION INCLUDED 5,817 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 81 YEARS OLD. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; AN UNDISCLOSED NUMBER OF PATIENTS WERE IMPLANTED WITH A MEDTRONIC COREVALVE, EVOLUT R, EVOLUT PRO OR EVOLUT PRO+ BIOPROSTHETIC VALVE. DEATHS OCCURRED IN THE STUDY POPULATION; HOWEVER, THERE WAS NO STATEMENT ESTABLISHING A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: ELEVATED MEAN TRANSVALVULAR PRESSURE GRADIENTS, PATIENT-PROSTHESIS MISMATCH AND MODERATE TO SEVERE PARAVALVULAR LEAK.  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839558 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Life Threatening| H