BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 20734257 · Received November 20, 2024

    Report

    Report Number
    2025587-2024-06678
    Event Type
    Death
    Date Received
    November 20, 2024
    Date of Event
    October 21, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: FEISTRITZER HJ, KURZ T, VONTHEIN R, ET AL. EFFECT OF VALVE TYPE AND ANESTHESIA STRATEGY FOR TAVR: 5-YEAR RESULTS OF THE SOLVE-TAVI TRIAL. J AM COLL CARDIOL. PUBLISHED ONLINE OCTOBER 21, 2024. DOI:10.1016/J.JACC.2024.09.007 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. 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 THE EFFECT OF VALVE TYPE AND ANESTHESIA STRATEGY IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). THE STUDY POPULATION CONSISTED OF 447 PATIENTS WHO UNDERWENT TAVR WITH EITHER A MEDTRONIC EVOLUT R SELF-EXPANDING VALVE (SEV) OR A NON-MEDTRONIC SAPIEN 3 BALLOON-EXPANDABLE VALVE (BEV). DURING FIVE YEARS OF FOLLOW-UP, THE AUTHORS RECORDED A TOTAL OF 97 DEATHS IN THE SEV GROUP AND CATEGORIZED THE DEATHS UNDER THE ¿VALVE-RELATED OUTCOMES.¿ OTHER VALVE-RELATED OUTCOMES THAT OCCURRED IN THE SEV GROUP: STROKE, MODERATE OR SEVERE PARAVALVULAR LEAK, AND PERMANENT PACEMAKER IMPLANTATION. KIDNEY FAILURE (ACUTE KIDNEY INJURY) WAS DOCUMENTED AS AN ANESTHESIA-RELATED OUTCOME. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007877 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Unknown Death