BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 8814131 · Received July 22, 2019

    Report

    Report Number
    2025587-2019-02294
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    September 14, 2017
    Report Date
    July 22, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ZHANG S AND KOLOMINSKY-RABAS PL. HOW TAVI REGISTRIES REPORT CLINICAL OUTCOMES-A SYSTEMATIC REVIEW OF ENDPOINTS BASED ON VARC-2 DEFINITIONS. PLOS ONE. 2017 SEP 14;12(9):E0180815. DOI: 10.1371/JOURNAL.PONE.0180815. 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 RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. (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 REGARDING AN OVERVIEW OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) REGISTRIES AND THE REPORTING CLINICAL OUTCOMES BASED ON THE VALVE ACADEMIC RESEARCH CONSORTIUM-2 (VARC-2) DEFINITIONS. ALL DATA WERE COLLECTED FROM A META-ANALYSIS REVIEW OF 69 STUDIES ORIGINATING FROM 20 TAVI REGISTRIES. THE OVERALL STUDY POPULATION INCLUDED 12,583 PATIENTS (DEMOGRAPHICS NOT PROVIDED), BETWEEN 1,316 AND 6,615 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 30-DAY (ALL-CAUSE AND CARDIOVASCULAR) AND 1-YEAR MORTALITY RATES WERE REPORTED. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION, CORONARY ARTERY OBSTRUCTION REQUIRING INTERVENTION, VALVE-RELATED DYSFUNCTION REQUIRING REPEAT PROCEDURE, ENDOCARDITIS, MYOCARDIAL INFARCTION, STROKE, THROMBOTIC COMPLICATIONS OF THE PROSTHETIC VALVE, MAJOR VASCULAR COMPLICATIONS, AND LIFE-THREATENING/DISABLING/MAJOR BLEEDING. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606324 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention