BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 20433432 · Received October 11, 2024

    Report

    Report Number
    2025587-2024-05664
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    June 27, 2024
    Report Date
    October 11, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: CHIANG CY, LIN SC, HSU JC, CHEN JS, HUANG JH, CHIU KM. REDUCING LEFT VENTRICULAR WALL STRESS THROUGH AORTIC VALVE ENLARGEMENT VIA TRANSCATHETER AORTIC VALVE IMPLANTATION IN SEVERE AORTIC STENOSIS. J CLIN MED. 2024;13(13):3777. PUBLISHED 2024 JUN 27. DOI: 10.3390/JCM13133777. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED IN THE ARTICLE: COREVALVE (PRODUCT CODE NPT, PMA# P130021), EVOLUT R (PRODUCT CODE NPT, PMA# P130021), AND EVOLUT PRO (PRODUCT CODE NPT, PMA# P130021). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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 LEFT VENTRICULAR PERFORMANCE AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). THE STUDY POPULATION CONSISTED OF (B)(4) PATIENTS WHO UNDERWENT TAVI WITH EITHER A MEDTRONIC VALVE BRAND (COREVALVE, EVOLUT R, EVOLUT PRO = (B)(4)) OR A NON-MEDTRONIC VALVE BRAND (MYVAL = (B)(4)). DURING FOLLOW-UP, A TOTAL OF (B)(4) DEATHS OCCURRED. THERE WAS NO EVIDENCE PRESENTED TO SUGGEST A CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. THE FOLLOWING ADVERSE OUTCOMES WERE ALSO DESCRIBED IN THE ARTICLE: REIMPLANTATION DUE TO MIGRATION; PERMANENT PACEMAKER IMPLANTATION DUE TO CONDUCTION DISTURBANCES (HIGH-DEGREE ATRIOVENTRICULAR BLOCK OR LEFT BUNDLE BRANCH BLOCK); NEED FOR VENTILATOR SUPPORT FOR MORE THAN 48 HOURS; ¿MORE THAN MILD¿ PARAVALVULAR LEAK (MODERATE OR SEVERE); ¿MAJOR ADVERSE CARDIAC EVENTS¿ (INCLUDED MYOCARDIAL ISCHEMIA REQUIRING INTERVENTION, CEREBRAL THROMBOEMBOLISM, HEART FAILURE NECESSITATING HOSPITALIZATION); AND ACUTE KIDNEY INJURY. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326553 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Life Threatening| R| H