BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7049021 · Received November 21, 2017

    Report

    Report Number
    2025587-2017-02228
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    December 15, 2015
    Report Date
    November 21, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KIM WK. MYOCARDIAL INJURY ASSOCIATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). CLIN RES CARDIOL. 2016 MAY;105( 5):379-87. DOI: 10.1007/S00392-015-0949-6 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. 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 MYOCARDIAL INJURY ASSOCIATED WITH TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS. THE STUDY POPULATION INCLUDED AN UNSPECIFIED NUMBER OF PATIENTS, AN UNDETERMINED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ONE-YEAR MORTALITY OCCURRED DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: APICAL ANEURYSM, VENTRICULAR SEPTAL PERFORATION, MILD TO MODERATE PARAVALVULAR LEAK (PVL). TWO PATIENTS SUFFERED MYOCARDIAL ISCHEMIA MONTHS FOLLOWING THE COREVALVE IMPLANT. ONE ANNULAR RUPTURE WITH A DISSECTION OF THE AORTIC ROOT AND ASCENDING AORTA WAS NOTED FOLLOWING THE POST-DILATATION OF AN OVERSIZED COREVALVE INTO A CALCIFIED ANNULUS. BASED ON THE AVAILABLE INFORMATION, THE ANNULAR RUPTURE WAS LIKELY ATTRIBUTED TO MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830686 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention