BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7848297 · Received September 5, 2018

    Report

    Report Number
    2025587-2018-02346
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    July 18, 2018
    Report Date
    September 5, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KANJANAHATTAKIJ N ET AL. COMPARING OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH STENOTIC BICUSPI D AND TRICUSPID AORTIC VALVE: A SYSTEMATIC REVIEW AND META-ANALYSIS. CLIN CARDIOL. 2018 JUL;41(7):896-902. DOI: 10.1002/CLC.22992. EPUB (B)(6) 2018. 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 META-ANALYSIS REEXAMINATION OF THE CURRENT EVIDENCE OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN PATIENTS WITH SEVERE AORTIC STENOSIS AND A BICUSPID AORTIC VALVE COMPARED WITH TRICUSPID AORTIC VALVE. ALL DATA WERE COLLECTED FROM A LITERATURE SEARCH USING THE MEDLINE AND EMBASE DATABASES AND THE RESULTS WERE MANUALLY SCREENED FROM ARTICLES PUBLISHED BETWEEN 2013 AND 2017. THE SYSTEMIC REVIEW IDENTIFIED AND SELECTED 9 STUDIES WITH A STUDY POPULATION THAT INCLUDED 4,469 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 78 YEARS), AN UNDISCLOSED NUMBER OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE OR A MEDTRONIC EVOLUT R BIOPROSTHETIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, CONVERSION TO OPEN AORTIC VALVE REPLACEMENT, MODERATE PARAVALVULAR LEAK, MAJOR BLEEDING, AND MAJOR VASCULAR COMPLICATIONS. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686060 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention