BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 14879320 · Received June 30, 2022

    Report

    Report Number
    2025587-2022-01818
    Event Type
    Death
    Date Received
    June 30, 2022
    Date of Event
    February 1, 2021
    Report Date
    June 30, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HAUSSIG ET AL. LONG-TERM FOLLOW-UP AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. CJC OPEN. 2021 FEB 1;3(7):845-853. DOI: 10.1016/J.CJCO.2021.01.012. ECOLLECTION 2021 JUL. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING LONG-TERM FOLLOW-UP AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JANUARY 2006 AND DECEMBER 2011. THE STUDY POPULATION INCLUDED 795 PATIENTS WHO WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 81 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 625 PATIENTS WERE IMPLANTED WITH A MEDTRONIC COREVALVE SELF-EXPANDING BIOPROSTHETIC VALVE. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS 11 DEATHS OCCURRED WITHIN 24 HOURS OF IMPLANT. TWO PATIENTS DIED OF COMPLICATIONS FROM ENDOCARDITIS AT DAYS 22 AND 105 POST-IMPLANT. NO FURTHER DETAILS WERE PROVIDED ON THE DEATHS. THERE WAS NO STATEMENT OF CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN MEDTRONIC PRODUCT AND THE DEATHS. HOWEVER, BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: MYOCARDIAL INFARCTION (MI), STROKE, ARRHYTHMIA REQUIRING PERMANENT PACEMAKER IMPLANT, MAJOR OR LIFE-THREATENING BLEEDING, CARDIAC TAMPONADE, ENDOCARDITIS, SEVERE STRUCTURAL VALVE DYSFUNCTION (SVD), MODERATE TO SEVERE AORTIC REGURGITATION (AR). BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT [WAS / 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
    366255 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death