BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7058156 · Received November 25, 2017

    Report

    Report Number
    2025587-2017-02266
    Event Type
    Injury
    Date Received
    November 25, 2017
    Date of Event
    April 1, 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
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SCHWIETZ T. OCCURRENCE AND PROGNOSTIC IMPACT OF SYSTEMIC INFLAMMATORY RESPONSE SYNDROME IN TRANSFEMORAL AND TRANSAPICAL AORTIC VALVE IMPLANTATION WITH BALLOON- AND SELF-EXPANDABLE VALVES. EUROINTERVENTION. 2015 APR;10(12):1468-73. DOI: 10.4244/EIJY14M06_05. 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 OCCURRENCE AND PROGNOSTIC IMPACT OF SYSTEMIC INFLAMMATORY RESPONSE SYNDROME IN TRANSFEMORAL AND TRANSAPICAL AORTIC VALVE IMPLANTATION WITH BALLOON- AND SELF-EXPANDABLE VALVES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2009 AND JULY 2011. THE STUDY POPULATION INCLUDED 192 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 80 YEARS), AN UNSPECIFIED NUMBER OF WHOM WERE IMPLANTED WITH MEDTRONIC COREVALVE® (SERIAL NUMBERS NOT PROVIDED). IT WAS REPORTED THAT NINE PATIENTS WHO EXPIRED WITHIN THE INITIAL 48 HOUR PERIOD POST-IMPLANT WERE EXCLUDED FROM THE STUDY; NO CAUSE OF DEATH WAS REPORTED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. IT WAS REPORTED THAT 10 PATIENTS WERE EXCLUDED FROM THE STUDY POPULATION DUE TO CONVERSION TO OPEN HEART SURGERY DURING THE IMPLANT PROCEDURE. 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
    837198 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention