BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 19574714 · Received June 20, 2024

    Report

    Report Number
    2015691-2024-04744
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 25, 2024
    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

    H11: ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA D6A. (IF IMPLANTED, GIVE DATE): DATE UPDATED "(B)(6) 2016". ADDED INFORMATION TO B5 (DESCRIBE EVENT OR PROBLEM) AND B7 (OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS). H11: ADDITIONAL NARRATIVE. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION TO H6 (HEALTH EFFECT CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). H11: MANUFACTURER ADDITIONAL NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR FURTHER INVESTIGATION, AS THE VALVE REMAINED IMPLANTED DUE TO A VALVE-IN-VALVE REPLACEMENT, AND NO IMAGES OR MEDICAL RECORDS WERE PROVIDED. CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESES FROM CALCIFYING. CALCIFICATION IS MOST COMMONLY RELATED TO PATIENT FACTORS AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION RELATED TO A MANUFACTURING DEFICIENCY. THE INSTRUCTIONS FOR USE (IFU) HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARD TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. THE REPORTED TYPE OF EVENT IS INCLUDED IN THE IFU. THE MOST LIKELY CAUSE IS PATIENT FACTORS, INCLUDING HYPERLIPIDEMIA.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 7300TFX25 VALVE IMPLANTED IN MITRAL POSITION UNDERWENT A VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND NINE (9) MONTHS DUE TO VALVE CALCIFICATION LEADING TO STENOSIS AND REGURGITATION. A 26MM TRANSCATHETER VALVE WAS IMPLANTED WITHIN THE EDWARDS SURGICAL VALVE. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A PATIENT WITH A 7300TFX25 VALVE IMPLANTED IN MITRAL POSITION UNDERWENT A VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND NINE (9) MONTHS DUE TO CALCIFICATION LEADING TO MODERATELY RESTRICTED LEAFLETS, SEVERE STENOSIS (MEAN GRADIENT 16MMHG AT 59BPM) AND MILD TO MODERATE REGURGITATION. AS REPORTED, THERE WAS AN ECHOGENIC MOBILE DENSITY SEEN ON THE ANTERIOR BIOPROSTHETIC LEAFLET ON THE VENTRICULAR SIDE MEASURING 0.4X0.3CM. THIS FAVORS DEGENERATIVE CHANGES/PROSTHETIC LEAFLET DEGENERATION AND IS ATYPICAL IN APPEARANCE AND LOCATION FOR VEGETATION OR THROMBUS. THE PATIENT PRESENTED WITH SEVERE SHORTNESS OF BREATH AND NYHA III-IV. A 26MM TRANSCATHETER VALVE WAS IMPLANTED WITHIN THE EDWARDS SURGICAL VALVE. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654917 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 7300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| R| L