BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 8632191 · Received May 22, 2019

    Report

    Report Number
    2025587-2019-01666
    Event Type
    Death
    Date Received
    May 22, 2019
    Date of Event
    January 24, 2005
    Report Date
    May 22, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BACH DS ET AL. TEN-YEAR OUTCOME AFTER AORTIC VALVE REPLACEMENT WITH THE FREESTYLE STENTLESS BIOPROSTHESIS. ANN THORAC SURG. 2005 AUG;80(2):480-6; DISCUSSION 486-7. DOI: 10.1016/J.ATHORACSUR.2005.03.027. PRESENTED AT THE FORTY-FIRST ANNUAL MEETING OF THE SOCIETY OF THORACIC SURGEONS, TAMPA, FL, JAN 24 ¿26, 2005. 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. WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 THE 10-YEAR OUTCOMES IN PATIENTS FOLLOWING AORTIC VALVE REPLACEMENT WITH A MEDTRONIC FREESTYLE BIOPROSTHESIS. ALL DATA WERE COLLECTED FROM EIGHT CENTERS BETWEEN 1997 AND JULY 2004. THE STUDY POPULATION INCLUDED 725 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 71 YEARS), ALL OF WHICH WERE IMPLANTED WITH A MEDTRONIC FREESTYLE BIOPROSTHESIS (SERIAL NUMBERS NOT PROVIDED). IT WAS NOTED THAT 19, 21, 23, 25, 27, AND 29 MM PROSTHESIS SIZED WERE USED. AMONG ALL PATIENTS, 278 DEATHS OCCURRED. OF THESE, 25 DEATHS WERE REPORTED TO BE ¿VALVE-RELATED.¿ BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THESE 25 DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS IN WHICH MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED INCLUDED: THROMBOEMBOLISM (112 CASES), PERMANENT NEUROLOGIC EVENT (46), TRANSIENT NEUROLOGICAL EVENT (59), THROMBOSIS (2), REOPERATION (31), PSEUDOANEURYSM (1) AND HEMORRHAGE (34). MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE FOLLOWING ADVERSE EVENTS: STRUCTURAL VALVE DETERIORATION (12 CASES, 10 REQUIRED REOPERATION), NONSTRUCTURAL VALVE DYSFUNCTION (2), ENDOCARDITIS (18 CASES, 10 REQUIRED REOPERATION), PARAVALVULAR LEAK (6), AORTIC REGURGITATION, VALVE EXPLANT (26), AND INCREASED GRADIENTS. IT WAS REPORTED THAT THE MECHANISM OF STRUCTURAL VALVE DETERIORATION WAS RELATED TO LEAFLET TEAR, AND THREE CASES INVOLVED LEAFLET CALCIFICATION. NONSTRUCTURAL VALVE DETERIORATION WAS DUE TO DILATION OF THE SINOTUBULAR JUNCTION (1) AND AORTIC ROOT PSEUDOANEURYSM (1). NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427050 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death