BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT FX VALVE

    MDR report key: 23812048 · Received December 15, 2025

    Report

    Report Number
    2025587-2025-06035
    Event Type
    Death
    Date Received
    December 15, 2025
    Date of Event
    October 15, 2025
    Report Date
    December 15, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: YOON ET AL. PHYSICIAN-MODIFIED LOW-PROFILE ENDO-BENTALL DEVICE FOR TREATING COMPLEX AORTIC DISEASES INVOLVING THE AORTIC ROOT. J VASC SURG CASES INNOV TECH. 2025 OCT 15;12(1):102016. DOI: 10.1016/J.JVSCIT.2025.102016. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. 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 A 77-YEAR-OLD MALE PATIENT WITH MULTIVESSEL CORONARY ARTERY DISEASE AND LEFT VENTRICULAR HYPERTROPHY WHO WAS REFERRED WITH AN INCIDENTAL AORTIC DISSECTION. SUBSEQUENTLY THE PATIENT UNDERWENT A PROCEDURE WITH IMPLANT OF A PHYSICIAN-MODIFIED ENDO-BENTALL DEVICE AND A SUPRA-AORTIC VESSEL DEBRANCHING. THE ENDO-BENTALL DEVICE WAS CREATED BY MODIFYING AND SUTURING TOGETHER A MEDTRONIC 34-MM EVOLUT FX BIOPROSTHETIC TRANSCATHETER VALVE AND A NON-MEDTRONIC THORACIC ENDOVASCULAR REPAIR (TEVAR) DEVICE. THE MODIFIED ENDO-BENTALL DEVICE WAS SUCCESSFULLY POSITIONED AND THEN FURTHER SUPPORTED BY PLACEMENT OF A NON-MEDTRONIC THORACIC STENT. THE PATIENT TOLERATED THE SURGERY, BUT UNFORTUNATELY DIED TWO WEEKS AFTER SURGERY FROM END-STAGE HEART FAILURE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324131 EVOLUT FX VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTFX-23

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Life Threatening| D| H| R