BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6949196 · Received October 13, 2017

    Report

    Report Number
    2025587-2017-01837
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    May 16, 2017
    Report Date
    September 28, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BOUREAU, A.S. MD. PREDICTORS OF HEALTH-RELATED QUALITY OF LIFE DECLINE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IN OLDER PATIENTS WITH SEVERE AORTIC STENOSIS. JOURNAL OF NUTRITION HEALTH AND AGING; (2017) 21(1):105-111 DOI 10.1007/S12603-016-0739-5 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING PREDICTORS OF HEALTH-RELATED QUALITY OF LIFE DECLINE AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT IN OLDER PATIENTS >75 YEARS). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN 2013 AND 2014. THE STUDY POPULATION INCLUDED 150 PATIENTS, WHO WERE IMPLANTED WITH EITHER A COREVALVE OR A NON-MEDTRONIC BALLOON EXPANDABLE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. SERIAL NUMBERS WERE NOT REPORTED. THE STUDY POPULATION WAS PREDOMINANTLY MALE; MEAN AGE 83.7 ± 4.6 YEARS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: ELECTROCARDIOGRAM (ECG) CHANGES, ATRIAL FIBRILLATION (AFIB), VASCULAR COMPLICATIONS, CARDIAC TAMPONADE OR VENTRICULAR PERFORATION AND SUBSEQUENT PERICARDIAL EFFUSION, CONVERSION TO SURGERY AND PERMANENT PACEMAKER IMPLANT. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728561 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention