BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 16547851 · Received March 15, 2023

    Report

    Report Number
    2015691-2023-11476
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 22, 2023
    Report Date
    May 12, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    UDI-DI
    00690103186277
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED: B4, D4, G3, G6, H2, H4, H6. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION.

    Additional Manufacturer Narrative · 0

    CALCIFICATION IS A WELL-RECOGNIZED FAILURE MODE OF BIOPROSTHETIC VALVES. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), AND MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE. 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. ALTHOUGH PATIENT FACTORS ARE BELIEVED TO PLAY A CRUCIAL ROLE IN THE DEVELOPMENT IN BIOPROSTHETIC TISSUE CALCIFICATION, THE UNDERLINE MECHANISM IS STILL NOT FULLY UNDERSTOOD.

    Additional Manufacturer Narrative · 0

    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. PLEASE REFERENCE MFR REPORT #2015691-2023-11475 FOR THE REPORT SUBMITTED ON THE PATIENT'S AORTIC VALVE.

    Description of Event or Problem · 0

    IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY THAT THIS PATIENT WITH A 29MM MITRAL VALVE, IMPLANTED FIVE (5) YEARS, NINE (9) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO CALCIFICATION AND STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. A 29MM TRANSCATHETER VALVE WAS IMPLANTED. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 29MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. THE PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT ALSO HAD A TRANSCATHETER AORTIC VALVE REPLACEMENT WITHIN THE SAME SURGERY. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758242 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX 00690103186277

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Hospitalization| L| R