BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23771820 · Received December 10, 2025

    Report

    Report Number
    9617601-2025-03364
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 10, 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
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: CONTE ET AL. STENT FRAME DEFORMATION OF SELF-EXPANDING TRANSCATHETER HEART VALVES IN BICUSPID AORTIC STENOSIS AND IMPACT ON VALVE PERFORMANCE. EUR HEART J CARDIOVASC IMAGING. 2025 NOV 26;26(12):1842-1851. DOI: 10.1093/EHJCI/JEAF195. 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 STENT FRAME DEFORMATION OF SELF-EXPANDING TRANSCATHETER HEART VALVES IN PATIENTS WITH BICUSPID AOR TIC STENOSIS. THE STUDY POPULATION INCLUDED 175 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 79 YEARS OLD. ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT R OR EVOLUT PRO BIOPROSTHETIC VALVE. AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: VALVE FRAME UNDER-EXPANSION, LEAFLET-LEVEL STENT FRAME DEFORMATION, HYPOATTENUATED LEAFLET THICKENING (HALT), MODERATE TO SEVERE AORTIC PARAVALVULAR REGURGITATION, STROKE, CORONARY OBSTRUCTION, MAJOR BLEEDING OR VASCULAR COMPLICATION, AND ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166993 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC MEXICO S. DE R.L. DE CV MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Hospitalization| L| R