BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COREVALVE REVALVING SYSTEM

    MDR report key: 6316252 · Received February 9, 2017

    Report

    Report Number
    2025587-2017-00222
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    October 3, 2016
    Report Date
    January 16, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: EFFECT OF PERMANENT PACEMAKER ON MORTALITY AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT CITATION: SCANDINAVIAN CARDIOVASCULAR JOURNAL (2017) 51(1):40-46 (DOI 10.1080/14017431.2016.1236982). AUTHORS: JONATHAN ENGBORG, CASPER RIECHEL-SARUP, OKE GERKE, HANS MICKLEY, NIELS CHRISTIAN SANDGAARD, HENRIK NISSEN <(>&<)> AXEL COSMUS PYNDT DIEDERICHSEN. EARLIEST DATE OF E-PUBLISH/PUBLISH WAS USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS 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 REGARDING THE EFFECT OF PERMANENT PACEMAKER IMPLANT ON MORTALITY AFTER THE IMPLANT OF A TRANSCATHETER BIOPROSTHETIC AORTIC VALVE. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN MARCH 2008 AND SEPTEMBER 2012. THE STUDY POPULATION INCLUDED 128 PATIENTS; 100 IMPLANTED WITH A MEDTRONIC COREVALVE AND 28 IMPLANTED WITH A NON MEDTRONIC TRANSCATHETER BIOPROSTHETIC AORTIC VALVE (SERIAL NUMBERS NOT PROVIDED). THE MEAN AGE OF THE PATIENTS IMPLANTED WITH A COREVALVE WAS 81 YEARS OF AGE AND WERE PREDOMINATELY FEMALE. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED 41 PERMANENT PACEMAKER IMPLANTATIONS (COREVALVE 38, NON MEDTRONIC 3). INDICATIONS FOR PERMANENT PACEMAKER IMPLANT INCLUDED 15 INCIDENTS OF COMPLETE HEART BLOCK (CHB), 3 INCIDENTS OF 2ND DEGREE HEART BLOCK, AND 1 INCIDENT OF SICK SINUS SYNDROME. TWENTY-TWO PATIENTS RECEIVED A PERMANENT PACEMAKER PROPHYLACTICALLY. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE TYPE OF CONDUCTION DISTURBANCES AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97136 COREVALVE REVALVING SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention