BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE 26MM AORTIC VALVE

    MDR report key: 5930386 · Received September 6, 2016

    Report

    Report Number
    2025587-2016-01402
    Event Type
    Injury
    Date Received
    September 6, 2016
    Date of Event
    January 1, 2013
    Report Date
    August 10, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: THE ATHENS TAVR REGISTRY OF NEWER GENERATION TRANSFEMORAL AORTIC VALVES: 30-DAY OUTCOMES CITATION: KONSTANTINOS SPARGIAS, KONSTANTINOS TOUTOUZAS, MICHAEL CHRISSOHERIS, ANDREAS SYNETOS, ANTONIS HALAPAS, IOANNIS PAIZIS, GEORGIOS LATSIOS, KONSTANTINOS STATHOGIANNIS, SPYRIDON PAPAMETZELOPOULOS, STAVROS HELLENIC JOURNAL OF CARDIOLOGY 2013 54: 18-24 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW TO EVALUATE THE PROCEDURAL, ECHOCARDIOGRAPHIC AND 30-DAY CLINICAL OUTCOMES OF PATIENTS UNDERGOING TRANSFEMORAL IMPLANTATION OF THE NEWER GENERATION AORTIC VALVES IN THE NON-RANDOMIZED USE OF THE TWO AVAILABLE VALVE TYPES ALL DATA WERE COLLECTED FROM 4 CENTERS BETWEEN OCTOBER 2009 AND SEPTEMBER 2011. THE STUDY POPULATION INCLUDED 126 PATIENTS (PREDOMINANTLY FEMALE); MEAN AGE 80 YEARS, 67 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, NO DEATHS WERE ATTRIBUTED TO THE MEDTRONIC PRODUCT. AMONG ALL PATIENTS, ADVERSE EVENTS ATTRIBUTED TO MEDTRONIC PRODUCT INCLUDED: MILD TO MODERATE AORTIC INSUFFICIENCY, 22 PACEMAKER IMPLANTATION (REASON NOT SPECIFIED), 5 VASCULAR EVENTS (NOT SPECIFIED). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579610 COREVALVE 26MM AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION MCS-P3-26-AOA-US

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention