BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7080567 · Received December 4, 2017

    Report

    Report Number
    2025587-2017-02344
    Event Type
    Injury
    Date Received
    December 4, 2017
    Date of Event
    October 1, 2017
    Report Date
    December 4, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SANKARAMANGALAM, K. MD ET AL. IMPACT OF CORONARY ARTERY DISEASE ON 30-DAY AND 1-YEAR MORTALITY IN PATIENTS UNDERGOING TRAN SCATHETER AORTIC VALVE REPLACEMENT: A META-ANALYSIS. J AM HEART ASSOC. (2017) OCT 11;6(10). PII: E006092 DOI 10.1161/JAHA.117.006092 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. 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 A REGARDING THE IMPLANT OF CORONARY ARTERY DISEASE IN PATIENTS WITH A TRANSCATHETER AORTIC VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A LITERATURE SEARCH OF SEARCH OF EMBASE, MEDLINE, AND THE COCHRANE LIBRARY. THE SEARCH IDENTIFIED 15 STUDIES AND ARTICLES PUBLISHED BETWEEN 2010 AND 2017. THE STUDY POPULATION INCLUDED 8013 PATIENTS, 4763 OF WHICH WERE IMPLANTED WITH A COREVALVE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION MEDIAN AGE 81.3 YEARS AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: CEREBRAL VASCULAR ACCIDENT (CVA), VASCULAR COMPLICATION, BLOOD LOSS, AND MYOCARDIAL INFARCTION (MI). 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
    857850 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention