BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 21954629 · Received May 2, 2025

    Report

    Report Number
    2025587-2025-03352
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    January 7, 2025
    Report Date
    May 2, 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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: YAMASHITA ET AL. TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION WITH NEWER GENERATION EVOLUT VALVE BY SIZE OF FAILED BIO PROSTHESIS. ANATOL J CARDIOL. JAN 7;29(3):118-123. 2025. 10.14744/ANATOLJCARDIOL.2024.4633. 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 TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION WITH NEWER GENERATION EVOLUT BIOPROSTHETIC VALVE BY SIZE OF DECOMPENSATED BIOPROSTHESIS. THE STUDY POPULATION INCLUDED 91 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEDIAN AGE OF 78 YEARS OLD. ALL PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT PRO OR EVOLUT PRO+ OR EVOLUT FX 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: CORONARY OCCLUSION, STROKE, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, HIGH GRADIENTS OVER 20 MMHG, PATIENT-PROSTHESIS MISMATCH, MODERATE AORTIC REGURGITATION, MYOCARDIAL INFARCTION, BIOPROSTHETIC VALVE DETERIORATION, AND CONGESTIVE HEART FAILURE REQUIRING HOSPITALIZATION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656396 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| L| H