BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 22357019 · Received June 30, 2025

    Report

    Report Number
    2015691-2025-05267
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    June 3, 2025
    Report Date
    August 4, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    UDI-DI
    00690103186253
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER 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.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, B5, B7, G3, G6, H2, H6 (CLINICAL CODE, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT PERFORMED, AS NO INFORMATION REGARDING A DEVICE FAILURE MODE WAS PROVIDED. FURTHERMORE, THERE IS NO ALLEGATION OF A MALFUNCTION WHICH COULD BE RELATED TO A MANUFACTURING NON-CONFORMANCE AND/OR ONE WAS NOT SUSPECTED OR CONFIRMED THROUGH INVESTIGATION; NO LABELING NON-CONFORMANCE/DEFICIENCY; NO DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR (DOC-0101337). ENGINEERING EVALUATION SUMMARY: THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. 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

    IT WAS REPORTED THAT A 25MM 7300TFX MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO UNKNOWN REASONS. TMVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE AND PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED AND LEARNED THROUGH CER 2025-18646-01 THAT A 25 MM 7300TFX MITRAL VALVE IN MITRAL POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO UNKNOWN REASONS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. TMVR WAS PERFORMED WITH A 26 MM 9750TFX TRANSCATHETER VALVE AND PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929643 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES LLC 7300TFX N/A 00690103186253

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Life Threatening| R| H