BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6251288 · Received January 13, 2017

    Report

    Report Number
    2025587-2017-00093
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    October 1, 2015
    Report Date
    December 15, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: LE ROUX, E. MID-TERM RESULTS OF TRANS-CATHETER AORTIC VALVE-IN-VALVE IMPLANTATION IN DEGENERATED AORTIC STENTLESS BIOPROST HESES. CANADIAN JOURNAL OF CARDIOLOGY; OCTOBER 2015; 31:S174. (DOI HTTP://DX.DOI.ORG/10.1016/J.CJCA.2015.07.371) 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.

    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 TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANT IN DEGENERATED AORTIC STENTLESS BIOPROSTHESES. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2008 AND FEBRUARY 2015. THE STUDY POPULATION INCLUDED 15 PATIENTS (MEAN AGE 69 YEARS, GENDER DATA NOT PROVIDED), 8 OF WHICH WERE PREVIOUSLY IMPLANTED WITH A MEDTRONIC FREESTYLE (SERIAL NUMBERS NOT PROVIDED) AND 3 OF WHICH RECEIVED A MEDTRONIC COREVALVE (SERIAL NUMBERS NOT PROVIDED) AS THE VALVE-IN-VALVE BIOPROSTHESIS. AMONG ALL PATIENTS TWO DEATHS OCCURRED AT 11 AND 35 MONTHS AFTER VALVE-IN-VALVE IMPLANTATION FROM NON-CARDIAC CAUSES. THESE DEATHS WERE NOT ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS ADVERSE EVENTS FOR THE PREVIOUSLY IMPLANT BIOPROSTHETIC VALVES INCLUDED SEVERE AORTIC REGURGITATION AND MINIMAL LEAFLET CALCIFICATION REQUIRING VALVE-IN-VALVE IMPLANT. AMONG ALL PATIENTS ADVERSE EVENTS FOLLOWING THE VALVE-IN-VALVE IMPLANT INCLUDED PARTIAL CORONARY OBSTRUCTION REQUIRING CORONARY ANGIOPLASTY, AND MODERATE PARAVALVULAR LEAK WHICH DID NOT REQUIRE INTERVENTION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33401 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention