BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 11202714 · Received January 20, 2021

    Report

    Report Number
    2025587-2021-00217
    Event Type
    Injury
    Date Received
    January 20, 2021
    Date of Event
    March 1, 2020
    Report Date
    January 20, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RESKOVIC LUKSIC V ET AL. GLOBAL AND REGIONAL MYOCARDIAL FUNCTION AND OUTCOMES AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION FOR AORTIC STENOSIS AND PRESERVED EJECTION FRACTION. J CARDIOVASC MED (HAGERSTOWN). 2020 MAR;21(3):238-245. DOI: 10.2459/JCM.0000000000000918. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT (MONTH AND YEAR VALID). 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 FROM A LITERATURE ARTICLE REGARDING THE EFFECTS OF TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) ON EARLY RECOVERY OF GLOBAL AND SEGMENTAL MYOCARDIAL FUNCTION. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 2008 AND 2014. THE STUDY POPULATION INCLUDED 62 PATIENTS AND WAS PREDOMINANTLY FEMALE WITH A MEAN AGE OF 85 YEARS. ALL PATIENTS WERE IMPLANTED WITH MEDTRONIC COREVALVE TRANSCATHETER VALVES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 28 DEATHS OCCURRED WITHIN 3.5 YEARS AFTER TAVI. OF THOSE, SIX DEATHS WERE CARDIAC-RELATED. THE CAUSES OF THE DEATHS WERE NOT CHARACTERIZED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION EARLY AFTER TAVI, STROKE, TRANSIENT ISCHEMIC ATTACK, REHOSPITALIZATION FOR HEART FAILURE, MILD TO MODERATE AORTIC REGURGITATION, TAMPONADE REQUIRING AN UNSPECIFIED TYPE OF SURGICAL DRAINAGE, FEMORAL ARTERY LESIONS, UNSPECIFIED NEED FOR RE-SHEATHING OR RECAPTURING THE VALVE, AND BLEEDING REQUIRING BLOOD TRANSFUSION. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS 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
    99529 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| L| R