BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 23652189 · Received November 25, 2025

    Report

    Report Number
    2015691-2025-09585
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 31, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    UDI-DI
    00690103176148
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED BECAUSE 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: PER DOC-0221939, 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 23MM 3300TFX AORTIC VALVE IN AORTIC POSITION IS UNDER EVALUATION FOR REINTERVENTION DUE TO CALCIFICATION WITH MODERATE TO SEVERE STENOSIS AFTER AN IMPLANT DURATION OF 8 YEARS, AND 11 MONTHS. THE PATIENT WAS INITIALLY BROUGHT IN FOR VIV CASE BUT WAS ABORTED DUE TO EFFUSION AND EXTRAVASATION ON ANGIOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147353 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES LLC 3300TFX N/A 00690103176148

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other