BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 12136450 · Received July 8, 2021

    Report

    Report Number
    2025587-2021-02129
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    May 26, 2020
    Report Date
    July 8, 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: TYCZYNSKI P, ET AL. MODIFIED CHIMNEY / SNORKEL STENTING OF THE LEFT MAIN CORONARY ARTERY AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. KARDIOL POL. 2020 AUG 25; 78 (7-8): 792-793. DOI: 10.33963/KP.15391. EPUB 2020 MAY 26. 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 A (B)(6) YEAR-OLD FEMALE PATIENT WITH A HISTORY OF MITRAL VALVE REPLACEMENT WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION WITH A 29 MM MEDTRONIC EVOLUT R (UNIQUE DEVICE IDENTIFIER NUMBER NOT PROVIDED) FOR CRITICAL AORTIC STENOSIS. AORTOGRAPHY PERFORMED IMMEDIATELY AFTER VALVE IMPLANTATION SHOWED BOTH LEFT AND RIGHT CORONARIES WITH UNOBSTRUCTED OSTIA. FIVE MONTHS LATER, THE PATIENT REPORTED EXERTIONAL DYSPNEA AND WAS READMITTED. ECHOCARDIOGRAPHY EXHIBITED DIFFUSED HYPOKINESIA OF THE LEFT VENTRICULAR (LV) ANTEROLATERAL WALL AND REDUCTION OF LV EJECTION FRACTION FROM 60% TO 30%. ELEVATED TROPONIN T LEVELS WERE ALSO NOTED. COMPUTED TOMOGRAPHY ANGIOGRAPHY AND NON-SELECTIVE CORONARY ANGIOGRAPHY REVEALED CORONARY FLOW IMPAIRMENT TO THE LEFT CORONARY ARTERY (LCA) DUE TO THE EVOLUT R BEING POSITIONED TOO HIGH WITH THE OSTIUM OF THE LEFT MAIN CORONARY ARTERY (LMCA) BELOW THE BIOPROSTHETIC LEAFLETS. CONSEQUENTLY, PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED AND A DRUG ELUTING STENT WAS IMPLANTED IN THE DISTAL LMCA. ECHOCARDIOGRAPHY WAS PERFORMED FOUR DAYS AFTER PCI, AND AGAIN EIGHT MONTHS LATER, REVEALING IMPROVED LV FUNCTION (EJECTION FRACTION OF 50% AND 60%, RESPECTIVELY). THE AUTHORS STATED THE EVOLUT R WAS INTENTIONALLY IMPLANTED HIGH TO AVOID INTERFERENCE WITH THE PREVIOUSLY IMPLANTED MITRAL PROSTHESIS, BUT UNINTENTIONALLY CAUSED A TOO HIGH VALVE POSITION (ABOVE THE LCA OSTIUM). PER THE AUTHORS, THIS ALLOWED MAINLY SYSTOLIC LCA INFLOW AND ONLY RESIDUAL DIASTOLIC LCA INFLOW BECAUSE OF ¿SMALL¿ PARAVALVULAR LEAK, WHICH MOST LIKELY CAUSED ISCHEMIC DETERIORATION OF LV FUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034107 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-29

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R