BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT R TRANSCATHETER AORTIC VALVE

    MDR report key: 8818877 · Received July 23, 2019

    Report

    Report Number
    2025587-2019-02308
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 23, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LEE J ET AL. EARLY TRANSCATHETER AORTIC VALVE FAILURE ACCOMPANIED WITH LEAFLET PERFORATION. KOREAN CIRC J. 2019 JUL;49(7): 642-643. HTTPS://DOI.ORG/10.4070/KCJ.2018.0457. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 VIA LITERATURE REGARDING A (B)(6) YEAR-OLD FEMALE PATIENT WHO PRESENTED WITH AGGRAVATED DYSPNEA AND CLASS IV HEART FAILURE. THE PATIENT HAD BEEN IMPLANTED WITH A 26 MM MEDTRONIC EVOLUT-R BIOPROSTHETIC VALVE 17 MONTHS PRIOR (NO SERIAL NUMBER PROVIDED). THE PATIENT WAS LATER DIAGNOSED WITH METHICILLIN-SENSITIVE STAPHYLOCOCCUS EPIDERMIDIS, ACUTE PYELONEPHRITIS AND RIGHT KNEE SEPTIC ARTHRITIS REQUIRING SURGICAL DEBRIDEMENT. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED SEVERE TRANSVALVULAR REGURGITATION. DURING SURGICAL INTERVENTION THE BIOPROSTHETIC VALVE RIGHT CORONARY CUSP WAS NOTED AS PERFORATED, AND THE VALVE WAS EXPLANTED. POST-EXPLANT HISTOPATHOLOGICAL ANALYSIS REVEALED EVIDENCE OF ENDOCARDITIS AND STRUCTURAL VALVE DETERIORATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611614 EVOLUT R TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTR-23

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R