BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 17285762 · Received July 10, 2023

    Report

    Report Number
    2015691-2023-14466
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    May 31, 2022
    Report Date
    August 17, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: THE SERIAL NUMBER WAS NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. DESPITE DUE DILIGENT ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THIS EVENT, NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. 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, NONCALCIFIC 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. SINCE THE VALVE IMPLANT DURATION IS UNKNOWN, AS A CONSERVATIVE APPROACH, AN IMPLANT DURATION OF BOTH LESS THAN 5 YEARS AND GREATER THAN 5 YEARS IS BEING CONSIDERED FOR THE EVALUATION. A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, PATIENT FACTORS LIKELY CAUSED OR CONTRIBUTED.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, THE ARTICLE WAS RECEIVED FOR PUBLICATION ON 21ST MAY 2022. THEREFORE, THIS WAS USED AS THE OCCURRENCE DATE. ARTICLE CITATION: HODGSON DMD, ELKHATEEB O, GAINER R, HIRSCH G, KOILPILLAI C, ALITER H. STRUCTURAL VALVE DETERIORATION OF BIOPROSTHESIS IN THE AORTIC POSITION: A SINGLE CENTER EXPERIENCE. J CARD SURG. 2022 37:4285 4292. DOI:10.1111/JOCS.17044. THE DEVICES WERE NOT RETURNED FOR EVALUATION. ATTEMPTS TO RETRIEVE THE DEVICES AND ADDITIONAL INFORMATION IS IN PROCESS. 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 "STRUCTURAL VALVE DETERIORATION OF BIOPROSTHESIS IN THE AORTIC POSITION A SINGLE CENTER EXPERIENCE", THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: FOUR PATIENTS WITH A VALVE MODEL 3300TFX IMPLANTED IN AORTIC POSITION UNDERWENT REOPERATION DUE TO STRUCTURAL VALVE DEGENERATION AFTER AN UNKNOWN IMPLANT DURATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120313 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| H