BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 21023794 · Received December 26, 2024

    Report

    Report Number
    2015691-2024-10054
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    December 3, 2024
    Report Date
    January 29, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    UDI-DI
    00690103176155
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: B4, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). ENGINEERING EVALUATION SUMMARY: BASED ON THE INFORMATION AVAILABLE, THE DEVICE WAS INTENTIONALLY USED OUTSIDE THE WAY IT WAS DESIGNED AND INTENDED. THE PERFORMANCE, SAFETY, EFFICACY, LONGEVITY, AND DURABILITY OF RINGS AND BIOPROSTHETIC VALVES HAVE NOT BEEN DETERMINED WHEN THE PRODUCT IS USED OUTSIDE THE SCOPE OF ITS INTENDED USE AND/OR ITS STUDIED POPULATION. STENOSIS, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT-RELATED CONTRIBUTING FACTORS. PER TECHNICAL SUMMARY DOC-0221939, REV B, SVD [STRUCTURAL VALVE DETERIORATION] 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..."" ALTERNATIVELY, NON-STRUCTURAL VALVE DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. STENOSIS IS MOST COMMONLY RELATED TO PATIENT FACTORS AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION RELATED TO A MANUFACTURING DEFICIENCY. 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. A DHR REVIEW WAS PERFORMED, AND NO RELATED MANUFACTURING NONCONFORMANCES WERE IDENTIFIED. 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 USE-RELATED ISSUE WITH A HAZARDOUS SITUATION; NO DEVICE-RELATED INFECTION; AND NO EVIDENCE OF A PRODUCT FAILURE WITH REGARD TO DESIGN, RELIABILITY, OR USE ERROR. PER DOC-0101337, REV Q, AND DOC-0076862, REV O, A CAPA/SCAR/PRA IS NOT REQUIRED, AS THERE ARE NO CONFIRMED PRODUCT OR LABELING NON-CONFORMANCES, AND NO OTHER TRIGGERS ARE MET. THE MOST LIKELY CAUSE IS PATIENT FACTORS, INCLUDING TETRALOGY OF FALLOT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL 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 3300TFX AORTIC VALVE IN THE PULMONIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, TWO (2) MONTHS DUE TO MILD/MODERATE PULMONARY STENOSIS. TPVR WAS COMPLETED WITH A 29MM 9600TFX TRANSCATHETER VALVE AND PATIENT WAS STABLE AND DISCHARGED TO HOME ON POD# 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2190395 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 3300TFX NA 00690103176155

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male Life Threatening| H| R