BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITROFLOW LXA

    MDR report key: 19225518 · Received May 1, 2024

    Report

    Report Number
    3004478276-2024-00133
    Event Type
    Death
    Date Received
    May 1, 2024
    Date of Event
    March 8, 2024
    Report Date
    June 13, 2024
    Manufacturer
    CORCYM CANADA CORP.
    Product Code
    LWR
    UDI-DI
    00896208000108
    PMA / PMN Number
    P060038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND MATERIAL RECORDS FOR THE DEVICE INVOLVED IN THIS EVENT, AS THEY PERTAIN TO THE REPORTED ISSUE, WERE RETRIEVED AND REVIEWED BY THE MANUFACTURER¿S QUALITY ENGINEERING. THE RESULTS CONFIRMED THAT THIS PROSTHESIS SATISFIED ALL REQUIRED MATERIAL, VISUAL, AND PERFORMANCE STANDARDS AT THE TIME OF MANUFACTURE AND RELEASE. BASED ON THE INFORMATION AVAILABLE, THE DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED AT THIS TIME. HOWEVER, FROM THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES WERE NOTED. AS REPORTED IN THE SCIENTIFIC LITERATURE, STRUCTURAL VALVE DETERIORATION IS THE MAJOR CAUSE OF FAILURE OF BIOPROSTHETIC HEART VALVES AND THE PRINCIPAL UNDERLYING PATHOLOGIC PROCESS IS CUSPAL CALCIFICATION. CALCIFICATION CAN ALSO CAUSE STENOSIS DUE TO CUSPAL STIFFENING. CALCIFIC DEPOSITS ARE USUALLY LOCALIZED TO CUSPAL TISSUE (INTRINSIC CALCIFICATION). IT IS POSSIBLE THAT THE PATIENT¿S CLINICAL HISTORY AND RISK FACTORS MAY HAVE CONTRIBUTED TO THE STRUCTURAL VALVE DETERIORATION OBSERVED IN THIS MITROFLOW VALVE. HOWEVER, LITTLE CLINICAL HISTORY WAS PROVIDED, AND THIS CANNOT ULTIMATELY BE CONFIRMED. IT SHOULD BE NOTED THAT STRUCTURAL VALVE DETERIORATION IS LISTED AS A POSSIBLE ADVERSE EVENT IN THE MITROFLOW IFU. FURTHERMORE, SINCE THE EXACT CAUSE OF PATIENT DEATH WAS NOT REPORTED, THE DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, A PATIENT WHO HAD A MITROFLOW VALVE LXA21 IMPLANTED ON (B)(6) 2013, WAS UNDER EVALUATION FOR TAVR DUE TO AORTIC STENOSIS. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT HAD A PMH OF BIOPROTHTETIC SAVR AND MITRAL ANNULOPLASTY RING IN 2013. THERE WAS PERSISTENT AFIB WITH CHA2DS2-VASC SCORE OF 4, VT, BIV ICD (B)(6) ORIGINAL IN (B)(6) 2013 AND UPGRADE TO BOSTON SCIENTIFIC IN (B)(6) 2023 ((B)(6) =LEAD TO RV REMAINS). REPORTEDLY, PATIENT WAS ADMITTED TO HOSPITAL ON (B)(6) 2024 WITH INCREASING BILATERAL LE SWELLING AND PAIN TO LEGS FOR A COUPLE DAYS. PATIENT WAS FOUND TO BE IN ACUTE CHRONIC DECOMPENSATED HEART FAILURE WITH BNP (B)(4), NEG TROP OF 32, CREAT 2.2 AND LACTIC ACID 1.2. PATIENT THEN WAS ADMITTED TO THE ICU. PATIENT'S TSH WAS NOTABLY HIGH AND FREE T3/T4 WAS LOW. PATIENT WAS SEEN BY ENDOCRINE FOR A DIFFERENTIAL OF MYXEDEMA COMA AND ADRENAL INSUFFICIENCY AND GIVEN IV SYNTHROID AND HYDROCORTISONE. PATIENT THEN REMAINED ON PRESSORS AND WAS TRANSFERRED TO IFH WITH MIXED CARDIOGENIC/METABOLIC SHOCK AND WAS FOUND TO HAVE SEVERE STENOSIS OF BOTH AORTIC AND MITRAL VALVES. AS SUCH, DUE TO THE COMPLEX MEDICAL HISTORY AND REDO STATUS, AND HIGH-RISK PATIENT FOR REDO SAVR; PATIENT WENT UNDER EVALUATE FOR POSSIBLE TAVR +/-TMVR. HOWEVER, NO TAVR WAS ULTIMATELY PERFORMED SINCE PATIENT PASSED AWAY ON (B)(6) 2024. BASED ON THE FURTHER INFORMATION RECEIVED, PATIENT HAD INCREASED FATIGUE AND INCREASED BILAT LEG SWELLING PRIOR TO ADMISSION. PATIENT DENIES SOB, CP, PALPITATIONS OR DIZZINESS. PATIENT'S ASSESSMENT WAS REPORTED AS FOLLOW: AORTIC BIOPROSTHESIS DYSFUNCTION; MODERATE TO SEVERE MR MIXED WITH MS S/P MITRAL ANNULOPLASTY 2013; ACUTE ON CHRONIC HFREF; AKI ON CKD ILL; LEG CELLULITIS; SEVERE HYPOTHYROIDISM; VT S/P AICD; NICM WITH LVEF 25% S/P BIV-ICD UPGRADE 2023; ASCENDING AORTA ANEURYSM; ANEMIA; ULCERATIVE COLITIS FLARE UP; AND RHEUMATIC ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144017 MITROFLOW LXA TISSUE HEART VALVE LWR CORCYM CANADA CORP. LXA21 00896208000108

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death