BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 23259954 · Received October 9, 2025

    Report

    Report Number
    9617601-2025-01918
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 9, 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
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: TOMII ET AL. SELF-EXPANDING VERSUS BALLOON-EXPANDABLE TRANSCATHETER HEART VALVES IN PATIENTS WITH EXCESSIVE AORTIC VALVE CUSP CALCIFICATION. AM HEART J. 2025 SEP 18:S0002-8703(25)00333-3. DOI: 10.1016/J.AHJ.2025.09.011. 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 SELF-EXPANDING VERSUS BALLOON-EXPANDABLE TRANSCATHETER HEART VALVES IN PATIENTS WITH EXCESSIVE AORTIC VALVE CUSP CALCIFICATION. THE STUDY POPULATION INCLUDED 1,345 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 82.2 YEARS OLD. MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION; MEDTRONIC DEVICES INCLUDED COREVALVE, EVOLUT R, EVOLUT PRO, AND EVOLUT PRO+ SELF-EXPANDING BIOPROSTHETIC VALVES. 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 IN THE SELF-EXPANDING VALE GROUP, CLINICAL OBSERVATIONS INCLUDED: CORONARY ARTERY OCCLUSION, HEMODYNAMIC INSTABILITY, VALVE MIGRATION, STROKE, MYOCARDIAL INFARCTION, MAJOR OR LIFE-THREATENING BLEEDING OR VASCULAR COMPLICATION, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, UNSPECIFIED STRUCTURAL VALVE DETERIORATION, AND UNPLANNED AORTIC VALVE REINTERVENTION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125918 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 82 YR Male Life Threatening| R| H