BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 20359065 · Received October 3, 2024

    Report

    Report Number
    2025587-2024-05487
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    July 3, 2024
    Report Date
    October 3, 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
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GALL, ET AL. BALLOON-EXPANDABLE VALVE FOR THE TREATMENT OF SELF-EXPANDING VALVE FAILURE THE NEED FOR A TAILORED APPROACH. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 29(13):102388 2024. DOI: 10.1016/J.JACCAS.2024.102388. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING AN 82-YEAR-OLD MALE PATIENT WHO FIVE YEARS PRIOR UNDERWENT IMPLANT OF A MEDTRONIC 26-MM EVOLUT R BIOPROSTHETIC VALVE. MORE RECENTLY THE PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA DUE TO SEVERE INTRA-VALVULAR AORTIC REGURGITATION RESULTING FROM COMPLETE PROLAPSE OF THE NONCORONARY CUSP.  SUBSEQUENTLY THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE WITH SUCCESSFUL IMPLANT OF A NON-MEDTRONIC BIOPROSTHETIC VALVE INSIDE THE EVOLUT R BIOPROSTHETIC VALVE.  AN ANGIOGRAM CONFIRMED A WELL-IMPLANTED DEVICE WITHOUT LEAKAGE OR CORONARY OBSTRUCTION. AN ELECTROCARDIOGRAM SHOWED SINUS RHYTHM WITHOUT SIGNIFICANT CONDUCTIVE DISORDER. THE PATIENT WAS DISCHARGED TWO DAYS POST-PROCEDURE WITH NO PARAVALVULAR LEAKAGE AND A FINAL RESIDUAL MEAN GRADIENT OF 13 MMHG. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015572 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-26

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Life Threatening| R| H