BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 24244491 · Received February 3, 2026

    Report

    Report Number
    2015691-2026-10754
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    January 11, 2024
    Report Date
    February 3, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D6A. IF IMPLANTED, GIVE DATE: THE IMPLANT DATE WAS ONLY KNOWN AS 2010. THUS, (B)(6) 2010 WAS USED TO CALCULATE THE MINIMUM IMPLANT DURATION. ADDITIONAL E1 (TELEPHONE NUMBER): (B)(6) AND H6 (TYPE OF INVESTIGATION) CODE: LABELLING REVIEW. H11: ADDITIONAL MANUFACTURER NARRATIVE: THIS REPORT SERVES AS BOTH THE INITIAL AND FINAL MEDICAL DEVICE REPORT (MDR), INCORPORATING THE FINDINGS FROM THE INVESTIGATION. THIS EVENT WAS PREVIOUSLY REPORTED UNDER REPORT ID: 2015691-2025-09536, WHICH INCLUDED FOUR PATIENTS. FOLLOWING RECEIPT OF NEW INFORMATION, EACH PATIENT CASE HAS NOW BEEN DOCUMENTED SEPARATELY, AND FOUR INDIVIDUAL REPORTS ARE BEING SUBMITTED. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. ARTICLE CITATION: TUFARO, V., MUKHOPADHYAY, S., OPADA, K., PATEL, K., OZKOR, M., BAUMBACH, A., AND MULLEN, M. J. (2025). SHORT-TERM OUTCOMES FOLLOWING TRANSCATHETER VALVE-IN-VALVE IMPLANTATION WITH PORTICO OR NAVITOR VALVES: THE BARTS HEART CENTER EXPERIENCE. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. HTTPS://DOI.ORG/10.1002/CCD.70176 THIS IS ONE OF TWENTY MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. REFER TO REPORT NUMBER ID 2015691-2025-09502, 2015691-2025-09503, 2015691-2025-09504, 2015691-2025-09548, 2015691-2025-09536, 2015691-2025-09549, 2015691-2025-09505, 2015691-2025-09563, 2015691-2025-09567, 2015691-2025-09569, 2015691-2025-09582, 2015691-2025-09550, 2015691-2026-10730, 2015691-2026-10739, 2015691-2026-10752 AND 2015691-2026-10753 FOR ADDITIONAL EVENTS WITHIN THE SAME ARTICLE. 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. STRUCTURAL VALVE DETERIORATION (SVD) IS AN ACQUIRED CONDITION, INTRINSIC TO BIOPROSTHETIC VALVES, CHARACTERIZED BY DETERIORATION OF THE LEAFLETS OR SUPPORTING STRUCTURES, LEADING TO THICKENING, CALCIFICATION, TEARING, OR DISRUPTION OF THE PROSTHETIC VALVE MATERIALS. THESE CHANGES RESULT IN VALVULAR DYSFUNCTION MANIFESTING AS STENOSIS AND/OR REGURGITATION WITH A CONSEQUENT DROP IN HEMODYNAMIC EFFICACY OF THE VALVE. SVD COMMONLY OCCURS WITH A CONSIDERABLY INCREASED RATE AFTER 10 YEARS. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE SHOWN THAT IT IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY CAUSE IS PATIENT FACTORS, INCLUDING AN IMPLANT DURATION OF 10 OR MORE YEARS. 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 THE REVIEW OF MEDICAL ARTICLE "SHORT-TERM OUTCOMES FOLLOWING TRANSCATHETER VALVE-IN-VALVE IMPLANTATION WITH PORTICO OR NAVITOR VALVES: THE BARTS HEART CENTER EXPERIENCE", CORRESPONDING AUTHOR TUFARO V, MUKHOPADHYAY S, OPADA K, ET AL., THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: ONE PATIENT WITH A VALVE MODEL 3300TFX23MM IMPLANTED IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 13 YEARS DUE TO DEGENERATION. A 23MM TRANSCATHETER VALVE WAS IMPLANTED WITHIN THE SURGICAL DEVICE WITH NO REPORT OF COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305907 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H