BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 9746718 · Received February 24, 2020

    Report

    Report Number
    2025587-2020-00549
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    August 6, 2019
    Report Date
    February 24, 2020
    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: RODRIGUEZ-GABELLA T ET AL. RENIN-ANGIOTENSIN SYSTEM INHIBITION FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 2019; 74(5):631-641. DOI: 10.1016/J.JACC.2019.05.055. 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. 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 COMPARATIVE STUDY OF PATIENTS USING RENIN-ANGIOTENSIN SYSTEM (RAS) INHIBITORS FOLLOWING THE IMPLANTATION OF TRANSCATHETER AORTIC VALVE REPLACEMENTS. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN AUGUST 2007 AND AUGUST 2017. THE STUDY POPULATION INCLUDED 2785 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 81 YEARS), AN UNKNOWN NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE AND EVOLUT R TRANSCATHETER VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, IT WAS REPORTED THAT THE IN-HOSPITAL MORTALITY RATE WAS 3.1%. THROUGH 3 YEARS OF FOLLOW-UP, 412 PATIENTS DIED FROM ALL CAUSES (235 PATIENTS TAKING RAS INHIBITORS AND 177 PATIENTS NOT TAKING RAS INHIBITORS), OF WHICH 197 PATIENTS DIED FROM CARDIOVASCULAR CAUSES (90 PATIENTS TAKING RAS INHIBITORS AND 107 PATIENTS NOT TAKING RAS INHIBITORS). NO FURTHER DETAILS ABOUT THE DEATHS WERE PROVIDED, AND 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: PERMANENT PACEMAKER IMPLANTATION, VALVE EMBOLIZATION, STROKE, CORONARY OBSTRUCTION, ANNULAR RUPTURE, CARDIAC TAMPONADE, MAJOR BLEEDING, CONVERSION TO OPEN SURGERY, NEW ONSET ATRIAL FIBRILLATION, PATIENT-PROSTHESIS MISMATCH. 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
    208028 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