BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 24244394 · Received February 3, 2026

    Report

    Report Number
    2015691-2026-10753
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    January 31, 2022
    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 2014. THUS, (B)(6) 2014 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 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 A LOGICAL AND EXPECTED CONSEQUENCE OF THE CHEMICAL, MECHANICAL, AND IMMUNOLOGICAL PROCESSES ASSOCIATED WITH BHV IMPLANTATION. THE COMMON ENDPOINT OF ALL THESE FACTORS IS CALCIFICATION AND DEGRADATION. 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. DESPITE THE ADVANCEMENTS IN THE HEART VALVE INDUSTRY, SVD COMMONLY BEGINS 7- 8 YEARS AFTER IMPLANTATION, WITH A CONSIDERABLY INCREASED RATE IN PATIENTS WITH PERTINENT COMORBIDITIES AND/OR AN IMPLANT DURATION OF GREATER THAN 10 YEARS. PRIOR INVESTIGATIONS AND EXTENSIVE LITERATURE REVIEW HAVE SHOWN THAT SVD IS PREDOMINANTLY RELATED TO PATIENT FACTORS AND IMPLANT DURATION RATHER THAN TO MANUFACTURING ISSUES. EVENTS RELATED TO DEVICE DESIGN, MANUFACTURING, OR USE ERROR TEND TO MANIFEST AT AN EARLIER IMPLANT DURATION. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE IS PATIENT FACTORS, INCLUDING AN IMPLANT DURATION OF 7 OR MORE YEARS, HYPERCHOLESTEROLEMIA AND SMOKER CONDITION. 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 7 YEARS AND 1 MONTH 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
    306288 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R