BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 6984020 · Received October 27, 2017

    Report

    Report Number
    2025587-2017-01936
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    February 26, 2016
    Report Date
    October 27, 2017
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KATHARINA HELLHAMMER. RED CELL DISTRIBUTION WIDTH IN ANEMIC PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION. WORLD J CARDIOL. 2016 FEB 26;8(2):220-30. DOI: 10.4330/WJC.V8.I2.220. 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. 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 BASELINE RED CELL DISTRIBUTION WIDTH (RDW) AND ANEMIA ON OUTCOME IN PATIENTS WITH AORTIC STENOSIS UNDERGOING TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN AUGUST 2009 TO AUGUST 2013. THE STUDY POPULATION INCLUDED 376 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 81 YEARS), AN UNKNOWN NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE® (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: THE NEED FOR PACEMAKER, MYOCARDIAL INFARCTION, STROKE, CONVERSION TO OPEN HEART SURGERY, SEPSIS, BLEEDING AND VASCULAR COMPLICATIONS. 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
    763701 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT HEART VALVES SANTA ANA CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention