BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 21965311 · Received May 6, 2025

    Report

    Report Number
    2015691-2025-03569
    Event Type
    Injury
    Date Received
    May 6, 2025
    Date of Event
    April 1, 2025
    Report Date
    July 30, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DYE
    UDI-DI
    00690103176155
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: 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, G3, G6, H2, H6 (INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). 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 TO 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 AND HYPERLIPIDEMIA.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, G3, G6, H2, H4, H6 (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 (B)(4). 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.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS: B4, B5, B7, G3, G6, H2, H6 (COMPONENT CODE, CLINICAL CODE, AND DEVICE CODE).

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 3300TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 25MM 11500A AORTIC VALVE AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO UNKNOWN REASON. REPORTEDLY, PATIENT WAS IN RECOVERY POST-OP. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 25MM 3300TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 25MM 11500A AORTIC VALVE AFTER AN IMPLANT DURATION OF 9 YEARS, 2 MONTHS DUE TO DEGENERATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. REPORTEDLY, PATIENT WAS STABLE AND IN RECOVERY POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67391 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES LLC 3300TFX N/A 00690103176155

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H| L