BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6298839 · Received February 2, 2017

    Report

    Report Number
    2025587-2017-00188
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    February 21, 2012
    Report Date
    February 6, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CORRADO T ET AL. COMPARISON OF COMPLICATIONS AND OUTCOMES TO ONE YEAR OF TRANSCATHETER AORTIC VALVE IMPLANTATION VERSUS SURGICAL AORTIC VALVE REPLACEMENT IN PATIENTS WITH SEVERE AORTIC STENOSIS. AM J CARDIOL. 2012 MAY 15;109(10):1487-93. (DOI 10.1016/J. AMJCARD.2012.01.364) EARLIEST DATE OF PUBLISH USED FOR EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE NUMBER OF PATIENTS IMPLANTED WITH COREVALVE.

    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 REGARDING OUTCOMES OF TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) VERSUS SURGICAL AORTIC VALVE REPLACEMENT (SAVR) IN PATIENTS WITH SEVERE AORTIC STENOSIS. ALL DATA WERE COLLECTED FROM TWO CENTERS FROM JANUARY 2005 THROUGH MARCH 2011. THE STUDY POPULATION INCLUDED 618 PATIENTS (PREDOMINANTLY FEMALE WITH A MEAN AGE OF 74 YEARS), 119 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 46 DEATHS OCCURRED WHICH INCLUDED ONE PROCEDURAL DEATH. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: PROSTHESIS UNDER EXPANSION, MODERATE REGURGITATION, MIGRATION, IMPROPER POSITION REQUIRING VALVE-IN-VALVE IMPLANT OR A SNARE, MYOCARDIAL INFARCTION, STROKE, BLEEDING, AND ARRHYTHMIA REQUIRING A PERMANENT PACEMAKER IMPLANT. 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.

    Description of Event or Problem · 1

    THE STUDY POPULATION INCLUDED 618 PATIENTS (PREDOMINANTLY FEMALE WITH A MEAN AGE OF 74 YEARS), 194 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78633 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention