BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART-VALVE, REPLACEMENT

    MDR report key: 7732062 · Received July 30, 2018

    Report

    Report Number
    2015691-2018-03059
    Event Type
    Death
    Date Received
    July 30, 2018
    Date of Event
    January 1, 2004
    Report Date
    July 5, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED AS THE DEVICE SERIAL NUMBER WAS NOT PROVIDED. THE EVENT STATES DEATH AND THE CAUSE OF DEATH IS UNKNOWN OR NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THROUGH REVIEW OF ARTICLE "STENTLESS VS. STENTED BIOPROSTHESIS FOR AORTIC VALVE REPLACEMENT: A CASE MATCHED COMPARISON OF LONG-TERM FOLLOW-UP AND SUBGROUP ANALYSIS OF PATIENTS WITH NATIVE VALVE ENDOCARDITIS" BY ANDREAS SCHAEFER ET AL (2018), THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE (1) VALVE RELATED DEATH OCCURRED DURING THE MEDIAN/LONG TERM FOLLOW UP. BACKGROUND: CURRENT RETROSPECTIVE EVIDENCE SUGGESTS SIMILAR CLINICAL AND SUPERIOR HEMODYNAMIC OUTCOMES OF THE SORIN FREEDOM SOLO STENTLESS AORTIC VALVE (SFS) (LIVANOVA PLC, (B)(4)) COMPARED TO THE CARPENTIER EDWARDS PERIMOUNT STENTED AORTIC VALVE (CEP) (EDWARDS LIFESCIENCES INC., (B)(4)). TO DATE, NO REPORTS EXIST DESCRIBING CASE-MATCHED LONG-TERM OUTCOMES AND ANALYSIS FOR TREATMENT OF NATIVE VALVE ENDOCARDITIS (NVE). METHODS: FROM 2004 THROUGH 2014, 77 CONSECUTIVE PATIENTS RECEIVED SURGICAL AORTIC VALVE REPLACEMENT (SAVR) WITH THE SFS. A CONTROL GROUP OF PATIENTS AFTER SAVR WITH THE CEP WAS RETRIEVED FROM OUR DATABASE AND MATCHED TO THE STUDY GROUP REGARDING 15 PARAMETERS INCLUDING PREOPERATIVE ENDOCARDITIS. ACUTE PERIOPERATIVE OUTCOMES AND FOLLOW-UP DATA WERE RETROSPECTIVELY ANALYZED. CONCLUSIONS: THE HEMODYNAMIC SUPERIORITY OF THE SFS WAS CONFIRMED IN THIS COMPARISON. HOWEVER, CLINICAL OUTCOMES IN TERMS OF SVD AND PVE RATES, AS WELL AS SURVIVAL AFTER NVE, WERE INFERIOR IN THIS STUDY. THEREFORE, AUTHORS ARE RELUCTANT TO RECOMMEND UTILIZATION OF THE SFS FOR TREATMENT OF NVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573649 HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Death