BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7058133 · Received November 25, 2017

    Report

    Report Number
    2025587-2017-02259
    Event Type
    Injury
    Date Received
    November 25, 2017
    Date of Event
    February 8, 2015
    Report Date
    November 25, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: O¿SULLIVAN CJ. IMPACT OF MITRAL REGURGITATION ON CLINICAL OUTCOMES OF PATIENTS WITH LOW-EJECTION FRACTION, LOW-GRADIENT SEVERE AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. CIRC CARDIOVASC INTERV. 2015 FEB;8(2):E001895. DOI: 10.1161 /CIRCINTERVENTIONS.114.001895. 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 THE IMPACT OF MITRAL REGURGITATION ON CLINICAL OUTCOMES OF PATIENTS WITH LOW-EJECTION FRACTION, LOW-GRADIENT SEVERE AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN AUGUST 2007 AND DECEMBER 2012. THE STUDY POPULATION INCLUDED 113 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 82 YEARS), 65 OF WHOM WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 29 DEATHS OCCURRED: TWENTY SIX WERE CARDIOVASCULAR RELATED; 3 CAUSES WERE NOT DISCUSSED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: AORTIC REGURGITATION FOLLOWING IMPLANT AND CONVERSION TO OPEN HEART SURGERY. 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 WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837181 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