BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6811751 · Received August 22, 2017

    Report

    Report Number
    2025587-2017-01451
    Event Type
    Injury
    Date Received
    August 22, 2017
    Date of Event
    December 28, 2016
    Report Date
    July 28, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: TANNAS J ET AL. PROSPECTIVE COMPARISON BETWEEN THREE TAVR DEVICES: ACURATE NEO VS. COREVALVE VS. SAPIEN XT. A SINGLE HEART TEAM EXPERIENCE IN PATIENTS WITH SEVERE AORTIC STENOSIS. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. 2017; 90:139-146. DOI. 10.1002/CCD.26837 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. 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 REGARDING COMPARISON BETWEEN THREE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2012 AND 2014. THE STUDY POPULATION INCLUDED 162 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 82 YEARS), 56 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: INCREASED MEAN GRADIENT, MODERATE/SEVERE AORTIC REGURGITATION, VALVE EMBOLIZATION/MIGRATION, SECOND VALVE IMPLANT, CORONARY ARTERY OBSTRUCTION, PERIPROCEDURAL MYOCARDIAL INFARCTION, STROKE, CARDIAC PERFORATION, CARDIAC TAMPONADE, MAJOR VASCULAR COMPLICATIONS, BLEEDING, EMERGENCY SURGICAL INTERVENTION, AND PERMANENT PACEMAKER IMPLANT. 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 WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592094 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention