BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8438736 · Received March 20, 2019

    Report

    Report Number
    2025587-2019-00996
    Event Type
    Injury
    Date Received
    March 20, 2019
    Date of Event
    February 19, 2019
    Report Date
    March 20, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: HERNANDEZ-VAQUERO D ET AL. TRANSCATHETER AORTIC VALVE EXPLANTATION IS USUALLY FEASIBLE AND EASY. ANN THORAC SURG. 2019 FEB 19. PII: S0003-4975(19)30225-5. DOI: 10.1016/J.ATHORACSUR.2019.01.035. [EPUB AHEAD OF PRINT] 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 THE 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 MALE PATIENT PRESENTED WITH ACUTE PULMONARY EDEMA. FIVE YEARS PRIOR, THE PATIENT UNDERWENT IMPLANT OF A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED) TO TREAT SYMPTOMATIC SEVERE AORTIC STENOSIS WITH MODERATE LEFT VENTRICULAR DYSFUNCTION. IMMEDIATELY FOLLOWING THE VALVE IMPLANT, AN ECHOCARDIOGRAM SHOWED MODERATE PARAVALVULAR REGURGITATION. THREE YEARS POST IMPLANT, ADDITIONAL ECHOCARDIOGRAPHY AFFIRMED THE MODERATE PARAVALVULAR REGURGITATION WITH NO INDICATION OF VALVE DEGENERATION. AT THE TIME OF PRESENTATION, IT WAS NOTED THAT ECHOCARDIOGRAPHY REVEALED ¿CRITICAL¿ AORTIC STENOSIS WITH APPARENT LEAFLET CALCIFICATION AND THE PATIENT¿S LEFT VENTRICULAR FUNCTION WAS SEVERELY IMPAIRED. SUBSEQUENTLY, THE COREVALVE WAS SURGICALLY REMOVED AND REPLACED WITH A MECHANICAL AORTIC VALVE (MANUFACTURER NOT IDENTIFIED). CLINICAL ASSESSMENT OF THE EXPLANTED VALVE EXHIBITED ¿FIBROBLASTS WITH NECROTIC AND DEVITALIZED AREAS AND CALCIFIC NODULES.¿ NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230125 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention