BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA VALVE WITH GLIDE TECHNOLOGY AORTIC VALVE 21MM

    MDR report key: 17469357 · Received August 4, 2023

    Report

    Report Number
    MW5120624
    Event Type
    Injury
    Date Received
    August 4, 2023
    Date of Event
    July 31, 2018
    Report Date
    July 26, 2023
    Manufacturer
    ST. JUDE MEDICAL / ABBOTT MEDICAL
    Product Code
    LWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    (B)(6). CONTACT PHONE NUMBER (B)(6). CONTACT ADDRESS: (B)(6). HISTORY OF PROSTHETIC PORCINE CARDIAC VALVE. DUE TO DETERIORATION OF THE PRODUCT HE IS REQUIRING INCREASE IN MEDICATION DUE TO HEART FAILURE. POSITIVE FOR RECENT HOSPITALIZATION. REPLACEMENT OF BOTH THE AORTIC VALVE AND THE MITRAL VALVE. PAPER MEDICAL RECORDS AVAILABLE WITH INFORMATION ON EACH VALVE. VALVE #I ST. JUDE MEDICAL EPIC VALVE MITRAL VALVE 25MM CATALOG II EI00-25M-00, LOT# 180424294, EXP 2022-03-20. VALVE 112 ST. JUDE MEDICAL TRIFECTA VALVE WITH GLIDE TECHNOLOGY AORTIC VALVE 21MM CATALOG II TFGT-21A, LOT# 16486560, EXP 2019-03-13. PLACEMENT AT (B)(6) HOSPITAL OF (B)(6) ON (B)(6) 2018. RECALL ON PRODUCT. TEE RESULTS: AORTIC VALVE: BIOPROSTHETIC AV PRESENT. LEAFLETS ARE MOBILE. THERE IS MODERATE TRANSVALVE AR. THE DI IS 0.41. AT IS 92MS. THE MG IS 28MMH MITRAL VALVE: BP MITRAL VALVE WELL SEATED, NO STENOSIS OR REGURGITATION. TEE REVEALS: (B)(6) 2023 NORMAL LV AND RV FUNCTION. THE BIOPROSTHETIC MITRAL VALVE IS WELL SEATED AND NO STENOSIS AND NORMAL WASH OUT JET. NO PARAVALVE LEAK. THE BIOPROSTHETIC TRIFECT AORTIC VALVE BAS MILD DEGENERATION CHANGES WITH NO STENOSIS, HOWEVER BAS MODERATE AR AND ALSO PATIENT PROSTHESIS PRESENT. NEED TO SWITCH TO COUMADIN DUE TO "VALVULAR" AFIB WITH LOCAL CARDIOLOGIST. POTENTIAL MIX-MATCH SIZE PER EXPERT OPINION. REFERENCE REPORT: MW5120625.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335514 TRIFECTA VALVE WITH GLIDE TECHNOLOGY AORTIC VALVE 21MM HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL / ABBOTT MEDICAL 16486560

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Life Threatening| S| H| R AMIODARONE 200 MG| APIXABAN 5MG| ASPIRIN 325MG| FUROSEMIDE 40MG| KETOCONAZOLE 2% CREAM| LISINOPRIL 200MG| METOPROLOL 50MG| ROSUVASTATIN 20MG| TRIAMCINOLONE 0.1%