BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7805620 · Received August 22, 2018

    Report

    Report Number
    2025587-2018-02210
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    March 10, 2018
    Report Date
    August 22, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: JANSEN R ET AL. EVALUATION OF MITRAL REGURGITATION BY AN INTEGRATED 2D ECHOCARDIOGRAPHIC APPROACH IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT. INT J CARDIOVASC IMAGING. 2018 AUG;34(8):1193-1204. DOI: 10.1007/S10554-018-1328-Y. EPUB (B)(6) 2018. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING MITRAL REGURGITATION SEVERITY IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) BY STANDARDIZED ASSESSMENT OF TWO-DIMENSIONAL TRANSTHORACIC ECHOCARDIOGRAPHY AND 1-YEAR ECHOCARDIOGRAPHIC AND CLINICAL OUTCOMES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN AUGUST 2008 AND DECEMBER 2014. THE STUDY POPULATION INCLUDED 213 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 80.4 ± 7.3 YEARS), 32 OF WHICH WERE IMPLANTED WITH A MEDTRONIC COREVALVE BIOPROSTHETIC VALVE. NO SERIAL NUMBERS WERE PROVIDED. ALL PATIENTS WERE ALIVE AT 1-YEAR FOLLOW-UP. AMONG ALL PATIENTS, THE OVERALL SURVIVAL AT 2.7 ± 1.2 YEARS AFTER TAVR WAS 80.3% (65 DEATHS). BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: NEW PERMANENT PACEMAKER IMPLANTATION, TAMPONADE, MYOCARDIAL INFARCTION, CEREBROVASCULAR ACCIDENT, VALVE MALPOSITION, ATRIAL FIBRILLATION, MODERATE/SEVERE AORTIC REGURGITATION, MODERATE/SEVERE MITRAL REGURGITATION, MITRAL STENOSIS, MODERATE HIGH AORTIC MEAN/PEAK GRADIENTS, AND HIGH LEFT VENTRICULAR EJECTION FRACTION. 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
    647775 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention