BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 4111205 · Received September 23, 2014

    Report

    Report Number
    2025587-2014-00689
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    October 17, 2013
    Report Date
    October 31, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE ARTICLE'S AUTHOR CONTACT. WITHOUT DEVICE-IDENTIFYING INFORMATION, MEDTRONIC¿S DATABASE COULD NOT BE SEARCHED TO DETERMINE IF ANY OF THESE EVENTS WERE PREVIOUSLY REPORTED. THIS IS THE SECOND OF TWO REPORTS REGARDING THIS JOURNAL ARTICLE. A SEPARATE REPORT HAS BEEN FILED FOR DEATHS LISTED IN THE ARTICLE. THE REPORTED EVENT DATE IS THE DATE THE ARTICLE WAS PUBLISHED ONLINE. (B)(4). LONG-TERM CLINICAL OUTCOMES 15 YEARS AFTER AORTIC VALVE REPLACEMENT WITH THE FREESTYLE STENTLESS AORTIC BIOPROSTHESIS AUTHORS: DAVID S. BACH, MD, AND NEAL D. KON, MD ANNALS OF THORACIC SURGERY FEBRUARY 2014, VOL. 97, ISSUE 2, PP. 544-551 PUBLISHED ONLINE OCT. 17, 2013 HTTP://DX.DOI.ORG/10.1016/J.ATHORACSUR.2013.08.047.

    Additional Manufacturer Narrative · 1

    BASED ON THE CONTENT OF THE ARTICLE, THERE WAS NO INFORMATION AS TO WHICH DEVICES WERE ASSOCIATED WITH THE ADVERSE EVENTS. A DEVICE HISTORY RECORDS REVIEW COULD NOT BE PERFORMED, AS THE DEVICE SERIAL NUMBERS WERE NOT PROVIDED. BASED ON THE LIMITED INFORMATION RECEIVED, A ROOT CAUSE CANNOT BE DETERMINED.

    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 FROM A MEDICAL JOURNAL ARTICLE EXAMINING LONG-TERM OUTCOMES FOR 725 PATIENTS FROM A MULTI-CENTER EVALUATION OVER A 15-YEAR PERIOD THAT THERE WERE 52 CASES OF REOPERATION DUE TO STRUCTURAL VALVE DETERIORATION ASSOCIATED WITH DIFFERENT SIZES OF THIS AORTIC BIOPROSTHETIC ROOT. OF THE 52 REOPERATIONS, 47 RESULTED IN EXPLANT OF THE BIOPROSTHESIS. REOPERATIONS WERE ATTRIBUTABLE TO SVD IN 31 PATIENTS, ENDOCARDITIS IN 10, AORTIC REGURGITATION IN 9 (PARAPROSTHETIC IN 7, COMBINED CENTRAL AND PARAPROSTHETIC IN 1, AND INDETERMINATE IN 1), AND NONSTRUCTURAL DYSFUNCTION IN 2. THE PATIENT STUDY POPULATION INCLUDED 725 PATIENTS FOR WHOM FOLLOW-UP WAS ACHIEVED FOR POST-IMPLANT TIME PERIODS RANGING FROM ZERO TO 18 YEARS, WITH A MEDIAN OF 7.8 YEARS. THE AVERAGE DEMOGRAPHICS OF THE COHORT AT DEVICE IMPLANT WERE 72 YEARS OF AGE (RANGE 36-91) AND 55% MALE. THE STUDY INCLUDED PATIENTS FROM EIGHT CENTERS, WITH SIX OF THE EIGHT CENTERS CONTINUING TO COLLECT CLINICAL OUTCOMES DATA AFTER TEN YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590524 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention