BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 12131262 · Received July 7, 2021

    Report

    Report Number
    2025587-2021-02122
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    August 5, 2020
    Report Date
    July 7, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: PYLKO A, ET AL. A SUCCESSFUL TRANSCATHETER AORTIC VALVE IMPLANTATION OF A BALLOON-EXPANDABLE VALVE FOR PARAVALVULAR LEAK IN A PATIENT WITH BICUSPID AORTIC VALVE AND HORIZONTAL AORTA. KARDIOL POL. 2020 NOV 25;78(11):1187-1188. DOI: 10.33963/KP.15544. EPUB 2020 AUG 5. EARLIEST DATE OF PUBLISH 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE CASE REPORT REGARDING AN (B)(6)-YEAR-OLD MALE PATIENT WITH A NATIVE BICUSPID AORTIC VALVE AND A HORIZONTAL AORTA (65° ANGLE BETWEEN THE HORIZONTAL PLANE AND THE AORTIC ANNULUS) WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A 34 MM MEDTRONIC EVOLUT R (UNIQUE DEVICE IDENTIFIER NUMBER NOT PROVIDED). IMMEDIATELY FOLLOWING VALVE IMPLANTATION, AORTOGRAPHY SHOWED SIGNIFICANT PARAVALVULAR LEAK (PVL), SO A BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 26 MM BALLOON. PERI-PROCEDURAL TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) EXHIBITED PROPER BUT RELATIVELY LOW VALVE POSITION AND MODERATE PVL. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WHERE PULMONARY EDEMA OCCURRED TWO DAYS AFTER VALVE IMPLANTATION. ON TTE, PVL WAS ASSESSED AS HEMODYNAMICALLY SIGNIFICANT. CONSEQUENTLY, A BAV WAS PERFORMED WITH A 30 MM BALLOON, BUT THE PVL DID NOT DECREASE. FOURTEEN DAYS FOLLOWING VALVE IMPLANTATION, A 29 MM EDWARDS SAPIEN 3 TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE INSIDE THE EVOLUT R AND RESOLVED THE PVL. FURTHER RECOVERY IN THE INTENSIVE CARE UNIT WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED WITH SIGNIFICANT CLINICAL IMPROVEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027972 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-34

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention