BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 19393754 · Received May 24, 2024

    Report

    Report Number
    2025587-2024-03097
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    January 1, 2024
    Report Date
    May 24, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MAEDA K, ET AL. MID-TERM CLINICAL OUTCOMES OF REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT IN JAPANESE PATIENTS. J TRANSCATHETER VALVE THER VOL. 6, NO. 1 (2024). DOI: 10.33290/JTVT.OA.24-0003 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT: JANUARY 01, 2024 (YEAR VALID). MEDTRONIC PRODUCTS REFERENCED: 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. SELECT PATIENT INFORMATION CANNOT BE INCLUDED IN REGULATORY REPORT DUE TO REGIONAL PRIVACY REGULATIONS. 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 OUTCOMES OF REDO-TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) IN JAPANESE PATIENTS. OF THE 16 PATIENTS WHO UNDERWENT REDO-TAVR, ONE HAD A MEDTRONIC COREVALVE THAT REQUIRED REPLACEMENT DUE TO SEVERE TRANSVALVULAR LEAK (CENTRAL REGURGITATION). MEDTRONIC SELF-EXPANDING (COREVALVE/EVOLUT R/EVOLUT PRO+ = 11) AND NON-MEDTRONIC BALLOON-EXPANDABLE (SAPIEN FAMILY = 5) VALVE TYPES WERE USED FOR REDO-TAVR. THE AUTHORS NOTED FREEDOM FROM ALL-CAUSE MORTALITY RATES OF 81.3%, 81.3%, AND 72.2% AT ONE YEAR, TWO YEARS, AND THREE YEARS AFTER REDO-TAVR, RESPECTIVELY. NO EVIDENCE WAS PRESENTED TO SUGGEST THAT A MEDTRONIC PRODUCT OR ITS FUNCTION CONTRIBUTED TO ANY OF THE DEATHS. AFTER REDO-TAVR, ADVERSE OUTCOMES ASSOCIATED WITH THE USE OF THE SELF-EXPANDING VALVE TYPES INCLUDED: STROKE/CEREBRAL INFARCTION, CORONARY OBSTRUCTION, HIGH RESIDUAL GRADIENT (= 20 MMHG), PATIENT-PROSTHESIS MISMATCH, STRUCTURAL VALVE DETERIORATION, AND MAJOR VASCULAR COMPLICATION (DISSECTION THAT OCCURRED DURING PASSAGE OF THE EVOLUT PRO+ DELIVERY SYSTEM THROUGH THE AORTIC ARCH). ONE INSTANCE OF A ¿LOW EXPANSION INDEX¿ WAS OBSERVED WITH A 26 MM EVOLUT R VALVE, RESULTING IN A RESIDUAL MEAN GRADIENT > 20 MMHG. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663481 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-26

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown