BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6349391 · Received February 22, 2017

    Report

    Report Number
    2025587-2017-00284
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    November 28, 2016
    Report Date
    February 28, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NUMBER OF PATIENTS IN THE STUDY POPULATION, NUMBER OF DEATHS, AND NUMBER OF LIFE-THREATENING BLEEDS.

    Additional Manufacturer Narrative · 1

    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

    CITATION: ARAI T ET AL. DIRECT COMPARISON OF FEASIBILITY AND SAFETY OF TRANSFEMORAL VERSUS TRANSAORTIC VERSUS TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC CARDIOVASC INTERV. 2016 NOV 28;9(22):2320-2325. DOI: 10.1016/J.JCIN.2016.08.009. 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). 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING OUTCOMES AMONG TRANSFEMORAL, TRANSAORTIC, AND TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM SINGLE CENTER BETWEEN JANUARY 2011 AND DECEMBER 2014. THE STUDY POPULATION INCLUDED 798 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 83 YEARS), 227 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS WERE NOT INCLUDED). AMONG ALL PATIENTS 53 DEATHS OCCURRED; NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: 13 MAJOR STROKE, 59 ACUTE KIDNEY INJURY, 29 LIFE-THREATENING BLEEDING, 14 ANNULAR RUPTURE, 71 MODERATE TO SEVERE PARAVALVULAR LEAK, AND 101 PERMANENT PACEMAKER IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING OUTCOMES AMONG TRANSFEMORAL, TRANSAORTIC, AND TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR). ALL DATA WERE COLLECTED FROM SINGLE CENTER BETWEEN JANUARY 2011 AND DECEMBER 2014. THE STUDY POPULATION INCLUDED 789 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 83 YEARS), 227 OF WHICH WERE IMPLANTED WITH MEDTRONIC COREVALVE (SERIAL NUMBERS WERE NOT INCLUDED). AMONG ALL PATIENTS 15 DEATHS OCCURRED; NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: 13 MAJOR STROKE, 59 ACUTE KIDNEY INJURY, 25 LIFE-THREATENING BLEEDING, 14 ANNULAR RUPTURE, 71 MODERATE TO SEVERE PARAVALVULAR LEAK, AND 101 PERMANENT PACEMAKER IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132032 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| R