BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7034317 · Received November 15, 2017

    Report

    Report Number
    2025587-2017-02138
    Event Type
    Injury
    Date Received
    November 15, 2017
    Date of Event
    October 2, 2017
    Report Date
    November 15, 2017
    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: AMAT-SANTOS, I MD, PHD ET AL. PROSTHETIC MITRAL SURGICAL VALVE IN TRANSCATHETER AORTIC VALVE REPLACEMENT RECIPIENTS. JACC CARDIOVASC INTERV (2017) OCT 9;10(19):1973-1981 DOI 10.1016/J.JCIN.2017.07.045. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING OUTCOMES OF PATIENTS WITH PROSTHETIC MITRAL VALVES UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN 2008 AND 2017. THE STUDY POPULATION INCLUDED 2,414 PATIENTS, WHICH WERE IMPLANTED WITH A CORE VALVE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE (42%) OR A NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 80.5 ± 7.7 YEARS. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: ELECTROCARDIOGRAM (ECG) CHANGES TREATED WITH A PERMANENT PACEMAKER IMPLANT, LEFT BUNDLE BRANCH BLOCK (LBBB), CEREBRAL VASCULAR ACCIDENT (CVA)/TRANSIENT ISCHEMIC ATTACK (TIA), BLOOD LOSS, SEPSIS, MODERATE TO SEVERE AORTIC REGURGITATION, MYOCARDIAL INFARCTION (MI) AND VALVE DISLODGMENT, THE IMPLANT OF A SECOND VALVE. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813541 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention