BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRIS RESILIA MITRAL VALVE

    MDR report key: 19835783 · Received July 26, 2024

    Report

    Report Number
    2015691-2024-05675
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 29, 2024
    Report Date
    September 25, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103205541
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. DEVICE EVALUATION: THE DEVICE WAS RETURNED TO EDWARDS FOR EVALUATION. CUSTOMER REPORT OF THROMBOSIS WAS CONFIRMED. FIBRIN-LIKE THROMBOTIC MATERIAL WAS OBSERVED ON ALL THREE LEAFLETS ON BOTH ASPECTS. FIBRIN-LIKE DEPOSITS WERE VISIBLE ON THE STENT CIRCUMFERENCE. SEWING RING CLOTH WAS CUT IN MULTIPLE AREAS AROUND THE VALVE. H11. ADDITIONAL MANUFACTURER NARRATIVE: AN ECHO VIDEO WAS RECEIVED AND REVIEWED BY AN EXPERT IN ECHOCARDIOGRAPHY. SHORT VIDEO CLIP, APPROXIMATELY 10 SECONDS IN DURATION, SHOWS AN ECHO-GENIC MASS APPEARING TO BE LOCATED WITHIN THE SURGICAL PROSTHESIS, MOST LIKELY A THROMBUS. THE VALVE LEAFLETS ARE NOT VISUALIZED, AND IT IS NOT POSSIBLE TO COMMENT UPON LEAFLET MOTION. NO COLOR FLOW MAPPING OR DOPPLER DATA PROVIDED TO PERFORM HEMODYNAMIC ASSESSMENT. 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.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION B4 (DATE OF THIS REPORT), B5 (DESCRIBE EVENT OR PROBLEM) AND G3 (DATE RECEIVED BY MANUFACTURER). 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. 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.

    Additional Manufacturer Narrative · 0

    H11. ADDITIONAL NARRATIVE/DATA: DEVICE HISTORY RECORD (DHR) FILES FOR THE AFFECTED DEVICE WERE REVIEWED AND THE DEVICE WAS FOUND TO MEET ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THROMBOSIS IS A WELL-RECOGNIZED COMPLICATION OF PROSTHETIC DEVICES. DEVICE THROMBOSIS IS THE FORMATION OF BLOOD CLOTS ON THE DEVICE/GRAFT. THERE MAY BE CASES OF INCIDENTAL FINDING BY IMAGING (CT SCAN) OF THICKEN LEAFLETS (HALT) WHEN THE PATIENT WILL BENEFIT FROM A CLOSE FOLLOW-UP AND MAY BE TREATED WITH ORAL ANTICOAGULANT. 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 MOST LIKELY CAUSE IS PATIENT FACTORS.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A 1140027 VALVE IMPLANTED IN MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF THREE (3) DAYS DUE TO THROMBOSIS CONFIRMED BY ECHOCARDIOGRAPHY. THE PATIENT WAS ON HEPARIN AT THE TIME OF THROMBOSIS. THROMBOSIS EVENT OCCURRED ON 2ND POSTOPERATIVE DAY. THE PATIENT DID NOT HAVE HISTORY OF A CLOTTING DISORDER AND/OR CLOTS. THE PATIENT PRESENTED WITH ACUTE HEART FAILURE AND PULMONARY EDEMA BEFORE THE EXPLANT PROCEDURE. A 11400M29 WAS IMPLANTED IN REPLACEMENT. THE PATIENT OUTCOME WAS NOTED AS TO BE RECOVERED.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION THAT A (B)(6) VALVE IMPLANTED IN MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF THREE (3) DAYS DUE TO THROMBOSIS CONFIRMED BY ECHOCARDIOGRAPHY. THE PATIENT WAS ON HEPARIN AT THE TIME OF THROMBOSIS. THROMBOSIS EVENT OCCURRED ON SECOND OPERATION DAY. THE PATIENT DID NOT HAVE HISTORY OF A CLOTTING DISORDER AND/OR CLOTS. HEPARIN-INDUCED THROMBOCYTOPENIA (HIT) TEST WAS NOT PERFORMED. THE PATIENT PRESENTED WITH ACUTE HEART FAILURE AND PULMONARY EDEMA BEFORE THE EXPLANT PROCEDURE. A 11400M29 VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT OUTCOME WAS NOTED AS TO BE RECOVERED AND WAS READY TO BE DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913951 MITRIS RESILIA MITRAL VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11400M 00690103205541

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Hospitalization| R| L