BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 17973905 · Received October 20, 2023

    Report

    Report Number
    2015691-2023-16949
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    November 22, 2021
    Report Date
    November 23, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. TISSUE DEGENERATION-RELATED STRUCTURAL DETERIORATION, EITHER CALCIFIC OR NON-CALCIFIC, ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVE. OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. DEGENERATION-RELATED STRUCTURAL DETERIORATION IS MOST COMMONLY RELATED TO PATIENT FACTORS AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION RELATED TO A MANUFACTURING DEFICIENCY. THE MOST LIKELY CAUSE IS PATIENT FACTORS, INCLUDING RHEUMATIC HEART DISEASE AND DIABETES.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: ARTICLE CITATION: (B)(6). SIMULTANEOUS TRANSCATHETER DUAL VALVE REPLACEMENT (MITRAL AND TRICUSPID VALVES): A CASE REPORT. PMID: (B)(4), PMCID: (B)(4). THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    THROUGH REVIEW OF MEDICAL ARTICLE " SIMULTANEOUS TRANSCATHETER DUAL VALVE REPLACEMENT (MITRAL AND TRICUSPID VALVES): A CASE REPORT" , CORRESPONDING AUTHOR DR. PIYUSH GARG, THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: A 57-YEAR-OLD FEMALE UNDERWENT A REPLACEMENT OF MITRAL AND TRICUSPID VALVES (PERIMOUNT 33 MM). IN 2011 THE PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT WITH PERIMOUNT 33 MM FOR RHEUMATIC HEART DISEASE. APPROXIMATELY NINE (9) YEARS AND TEN (10) MONTHS LATER, THE PATIENT'S ECHOCARDIOGRAPHY SHOWED DYSFUNCTIONAL PROSTHETIC HEART VALVE (PHV) AT THE MITRAL POSITION, MODERATE VALVULAR MITRAL REGURGITATION (MR), PHV LEAFLETS WERE THICKENED WITH RESTRICTED VALVE OPENING RESULTING IN SIGNIFICANT STENOSIS DUE TO DEGENERATION. HIGH PEAK (12MMHG) AND MEAN GRADIENT (7MMHG), VMAX 176 CM/S ACROSS THE MITRAL BIOPROSTHETIC VALVE. THE PATIENT PRESENTED WITH DYSPNEA NHYA III, OEDEMA FEET, ASCITES, AND PALPITATIONS FOR THE LAST SIX (6) MONTHS. AS A CONSEQUENCE, A TRANSCATHETER MITRAL REPLACEMENT WAS PERFORMED UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS SUCCESSFUL WITH A FAVORABLE OUTCOME, SHORT HOSPITAL STAYS, AND EARLY RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642440 NI REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES NI

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention| L| H