BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7744909 · Received August 2, 2018

    Report

    Report Number
    2025587-2018-01962
    Event Type
    Injury
    Date Received
    August 2, 2018
    Date of Event
    February 5, 2015
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: NIJENHUIS VJ ET AL. ANTITHROMBOTIC TREATMENT IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). THROMB HAEMOST. 2015 APR;113(4):674-85. DOI: 10.1160/TH14-10-0821. EPUB 2015 FEB 5. 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.

    Additional Manufacturer Narrative · 1

    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 THE VARIATIONS IN ANTITHROMBOTIC TREATMENT REGIMENS PRESCRIBED TO PATIENTS FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) AND DESCRIBE THE CONSEQUENCES OF ISCHEMIC AND BLEEDING COMPLICATIONS ASSOCIATED WITH TAVI. ALL DATA WERE COLLECTED FROM A LITERATURE SEARCH USING THE PUBMED, EMBASE, AND COCHRANE DATABASES AND THE RESULTS WERE SCREENED FROM ORIGINAL ARTICLES PUBLISHED BETWEEN FEBRUARY 2004 AND SEPTEMBER 2014. THE SYSTEMIC REVIEW IDENTIFIED AND SELECTED 25 STUDIES; 4 OF WHICH WERE GENERAL RANDOMIZED TRIALS, 17 WERE REGISTRIES MENTIONING THE ANTIPLATELET REGIMEN AFTER TAVI, 2 WERE RANDOMIZED TRIALS TO THE ANTIPLATELET REGIMEN AFTER TAVI, AND 2 WERE RETROSPECTIVE STUDIES TO THE ANTIPLATELET REGIMEN AFTER TAVI. THE STUDY POPULATION INCLUDED 6,752 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 83 YEARS), AN UNDISCLOSED NUMBER OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STROKE (OVER 50 % OF ALL STROKES WITHIN 30 DAYS IS ACUTE AND OCCURS WITHIN 24 HOURS AFTER TAVI), MYOCARDIAL INFARCTION, AND MINOR/MAJOR/LIFE THREATENING BLEEDING. 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
    586728 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening