BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC TRANSCATHETER VALVE

    MDR report key: 21389893 · Received February 14, 2025

    Report

    Report Number
    2025587-2025-01262
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    October 28, 2024
    Report Date
    February 14, 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
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: AVVEDIMENTO ET AL. HEMODYNAMIC PERFORMANCE OF THE SAPIEN 3 ULTRA RESILIA VALVE: INSIGHTS FROM A PROPENSITY-MATCHED ANALYSIS. J AM SOC ECHOCARDIOGR. 2025 FEB;38(2):132-135. DOI: 10.1016/J.ECHO.2024.10.007. EPUB 2024 OCT 28. 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. 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 HEMODYNAMIC PERFORMANCE OF THE SAPIEN 3 ULTRA RESILIA VALVE THRU A PROPENSITY-MATCHED ANALYSIS. THE STUDY POPULATION INCLUDED 415 PATIENTS.  MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 127 PATIENTS WERE IMPLANTED WITH A MEDTRONIC EVOLUT R, EVOLUT PRO, EVOLUT PRO+ OR EVOLUT FX BIOPROSTHETIC VALVE.  AMONG ALL PATIENTS, CLINICAL OBSERVATIONS INCLUDED: SEVERE PATIENT-PROSTHESIS MISMATCH, MEAN GRADIENTS >20 MMHG, AND MODERATE TO SEVERE AORTIC REGURGITATION (AR).  NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126577 MEDTRONIC TRANSCATHETER VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION MDT-TRANS VALVE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L