BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6904626 · Received September 29, 2017

    Report

    Report Number
    2025587-2017-01720
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    January 12, 2016
    Report Date
    September 20, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ABRAMOWITZ, YIGAL MD ET AL. IMPACT OF BODY MASS INDEX ON THE OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2016) 88:127¿134 DOI: 10.1002/CCD.26394 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). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING THE IMPACT OF BODY MASS INDEX (BMI) ON THE OUTCOMES FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2012 AND 2015. THE STUDY POPULATION INCLUDED 805 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 82.0 ± 8.8 YEARS). PATIENTS WERE IMPLANTED WITH EITHER A COREVALVE (9.4%) OR A NON MEDTRONIC BALLOON EXPANDABLE TRANSCATHETER BIOPROSTHETIC AORTIC VALVE (90.6%) (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENT ADVERSE EVENTS INCLUDED: VALVE DISLODGEMENT, PARAVALVULAR LEAK (PVL), INCREASED GRADIENT MEASUREMENTS, VALVE-IN-VALVE IMPLANT, MYOCARDIAL INFARCTION (MI), CEREBRAL VASCULAR ACCIDENT (CVA), TRANSIENT ISCHEMIC ATTACK (TIA), BLEEDING, VASCULAR COMPLICATIONS, ELECTROCARDIOGRAM (ECG) CHANGES TREATED WITH PERMANENT PACEMAKER IMPLANT, CARDIOGENIC SHOCK AND CARDIAC TAMPONADE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684954 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention