BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 23783365 · Received December 11, 2025

    Report

    Report Number
    9617601-2025-03398
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    October 21, 2025
    Report Date
    December 11, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: YAN ET AL. ASSOCIATION OF BICUSPID AORTIC VALVE STENOSIS WITH HIGHER RISK FOR HYPOATTENUATED LEAFLET THICKENING FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT. CARDIOVASC DIAGN THER. 2025 OCT 31;15(5):1020-1031. DOI: 10.21037/CDT-2025-64. EPUB 2025 OCT 21. 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 ASSOCIATION OF BICUSPID AORTIC VALVE STENOSIS WITH HIGHER RISK FOR HYPOATTENUATED LEAFLET THICKENING FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT. THE STUDY POPULATION INCLUDED 605 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 73.9 YEARS OLD. MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 76 PATIENTS WERE IMPLANTED WITH A MEDTRONIC 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: HYPOATTENUATED LEAFLET THICKENING (HALT), CARDIAC TAMPONADE, MAJOR BLEEDING OR VASCULAR COMPLICATION, CORONARY OBSTRUCTION, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, STROKE, ELEVATED MEAN GRADIENTS OF 14 MMHG, MODERATE TO SEVERE PARAVALVULAR AORTIC REGURGITATION, SECOND VALVE IMPLANTED FOR UNSPECIFIED REASON, AND CONVERSION TO OPEN SURGERY. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2693682 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV EVOLUTPRO-23

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| H| L