BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 10126111 · Received June 5, 2020

    Report

    Report Number
    2025587-2020-01818
    Event Type
    Injury
    Date Received
    June 5, 2020
    Date of Event
    March 29, 2019
    Report Date
    June 5, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: NASCIMENTO H ET AL. TAVI IN TAVI: NEW PARADIGM. ACTA CARDIOLOGICA. 2020; 75(2):172-174. DOI: 10.1080/00015385.2019.1569311. 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 MALE PATIENT WITH A MEDICAL HISTORY OF SEVERE AORTIC STENOSIS WHO UNDERWENT IMPLANT OF A 29MM MEDTRONIC COREVALVE TRANSCATHETER VALVE. NO SERIAL NUMBERS WERE PROVIDED. IMMEDIATELY POST IMPLANT, A MILD PARAVALVULAR LEAK WAS OBSERVED BECAUSE OF ITS RELATIVELY LOW POSITION IN THE AORTIC ANNULUS. A FEW MONTHS LATER, THE PATIENT DEVELOPED PROGRESSIVE HEART FAILURE AND THE PARAVALVULAR LEAK ADVANCED TO SEVERE. THE PATIENT ALSO HAS LEFT VENTRICULAR DILATION AND MODERATE-SEVERE LEFT VENTRICULAR SYSTOLIC DYSFUNCTION. A BALLOON POST-DILATION WAS UNSUCCESSFUL, AND ULTIMATELY A NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588108 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention