BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MITRIS RESILIA MITRAL VALVE

    MDR report key: 20202637 · Received September 12, 2024

    Report

    Report Number
    2015691-2024-07054
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    July 18, 2024
    Report Date
    October 17, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103205541
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    THE DEVICE HISTORY RECORD (DHR) WAS NOT REVIEWED AS THE REPORTED EVENT DOES NOT ALLEGE A MALFUNCTION THAT COULD BE RELATED TO AN EDWARDS MANUFACTURING DEFICIENCY AND/OR ONE WAS NOT CONFIRMED THROUGH INVESTIGATION. THE MOST LIKELY CAUSE IS PROCEDURAL FACTORS.

    Description of Event or Problem · 0

    THROUGH MEDICAL RECORDS OF 2024-19941-01, IT WAS LEARNED THAT DURING IMPLANTATION OF A 27MM 11400M CAUSED DISTORTION OF THE NATIVE AV LEADING TO COMMISUROPLASTY TO THE COMMISSURE BETWEEN THE LEFT CORONARY CUSP AND THE NONCORONARY CUSP. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH DYSPNEA ON EXERTION AND UNDERWENT REDO- MVR. UPON EXPOSURE OF THE 27MM 73000TFX , THERE WAS SIGNIFICANT SCAR TISSUE AROUND THE SEWING RING OF THE OLD VALVE, WHICH WAS QUITE DIFFICULT TO REMOVE. DEBRIDEMENT AND REMOVAL OF CALCIUM AT THE ANNULAR TISSUE WAS DONE. A 27MM 11400M VALVE WAS THEN IMPLANTED. THE VALVE WAS SEATED WITH GOOD CLEARANCE OF ALL 3 STRUTS. TEE SHOWED GOOD MITRAL VALVE FUNCTION WITH NO PVL AND MODERATE AORTIC INSUFFICIENCY WHICH WAS NOT SEEN PREOPERATIVELY. IT APPEARED THAT THE NONCORONARY CUSP WAS SOMEWHAT TETHERED. THE SURGEON WAS CONCERNED THAT THIS COULD BE SOME DISTORTION FROM THE NEW MITRAL VALVE GIVEN THE SCAR TISSUE ,AS WELL AS THE OVERALL SMALL AND CRAMPED SPACE FOR THE PROSTHETIC MV . THE HEART WAS RE-ARRESTED AND A SMALL AORTOTOMY WAS MADE TO EXPLORE THE AORTIC VALVE. THIS DISTORTION WAS EXACTLY WHAT WAS OBSERVED. PLEDGETS FROM THE MITRAL VALVE REPLACEMENT WERE QUITE CLOSE UNDERNEATH THE COMMISSURE BETWEEN THE LEFT CORONARY CUSP AND NONCORONARY CUSP THAT LIKELY DISTORTED SOME OF THE NONCORONARY CUSP FUNCTION. THE SURGEON DID NOT WANT TO PROCEED WITH AVR GIVEN THE SMALL AORTIC ROOT AND INABILITY TO DO ANY ROOT ENLARGEMENT DUE TO THE PLACEMENT OF THE UNDERLYING MITRAL VALVE. A COMMISSUROPLASTY (2024-19941-02) AT THE COMMISSURE BETWEEN THE LEFT CORONARY CUSP AND THE NONCORONARY CUSP WAS PERFORMED WITHOUT IMPROVEMENT. ALL VALVES WERE INSPECTED ONCE AGAIN WITH THE MITRAL VALVE AGAIN IN GOOD FUNCTION WITH NO PARAVALVULAR LEAK. THERE WAS STILL MILD TO POSSIBLY MODERATE AORTIC INSUFFICIENCY BUT NO FLOW REVERSAL. THE PATIENT WAS TRANSPORTED TO CICU POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592078 EDWARDS MITRIS RESILIA MITRAL VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11400M27 00690103205541

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| L| H