BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE TRANSCATHETER AORTIC VALVE

    MDR report key: 7108512 · Received December 12, 2017

    Report

    Report Number
    2025587-2017-02414
    Event Type
    Injury
    Date Received
    December 12, 2017
    Date of Event
    May 19, 2015
    Report Date
    December 12, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: TEMPIO D. VENTRICULAR ARRHYTHMIAS IN AORTIC VALVE STENOSIS BEFORE AND AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. EUROPACE. 2015 JUL;17(7):1136-40. DOI 10.1093/EUROPACE/EUU362 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 VENTRICULAR ARRHYTHMIAS IN AORTIC VALVE STENOSIS BEFORE AND AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JUNE 2007 AND NOVEMBER 2012. THE STUDY POPULATION INCLUDED 146 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 81 YEARS), 126 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE DEVICE. SERIAL NUMBERS FOR THE DEVICES WERE NOT PROVIDED. AMONG ALL PATIENTS PERI-PROCEDURAL DEATH, IN-HOSPITAL, 30-DAY AND 12 MONTH MORTALITY OCCURRED DUE TO UNSPECIFIED CAUSES. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PERMANENT PACEMAKER IMPLANTATION, LEFT BUNDLE BRANCH BLOCK, AND VENTRICULAR ARRHYTHMIAS. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A 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
    887664 COREVALVE TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention