BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SAPIEN 3 VALVE

    MDR report key: 19545066 · Received June 17, 2024

    Report

    Report Number
    2015691-2024-04639
    Event Type
    Injury
    Date Received
    June 17, 2024
    Report Date
    June 17, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: KOBAYASHI Y, NAGAI T, KAMIYA K, TSUNETA S, SHINGU Y, WAKABAYASHI K, KUDO K, MATSUNO Y, WAKASA S, ANZAI T. CHRONIC ACTIVE MYOCARDITIS AFTER TRANSAPICAL TRANSCATHETER AORTIC VALVE IMPLANTATION. CIRC J. 2024 MAY 24;88(6):1008. DOI: 10.1253/CIRCJ.CJ-23-0910. EPUB 2024 MAY 8. PMID: 38644167. PER THE INSTRUCTIONS FOR USE (IFU), HEART FAILURE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE PROCEDURE AND THE USE OF THE EDWARDS DEVICES. HEART FAILURE IS WHEN THE HEART IS UNABLE TO PUMP SUFFICIENTLY TO MAINTAIN BLOOD FLOW TO MEET THE BODY'S NEEDS. SIGNS AND SYMPTOMS COMMONLY INCLUDE SHORTNESS OF BREATH, EXCESSIVE TIREDNESS, AND LEG SWELLING. THE SHORTNESS OF BREATH IS USUALLY WORSE WITH EXERCISE, WHILE LYING DOWN, AND MAY WAKE THE PERSON AT NIGHT. A LIMITED ABILITY TO EXERCISE IS ALSO A COMMON FEATURE. CHEST PAIN, INCLUDING ANGINA, DOES NOT TYPICALLY OCCUR DUE TO HEART FAILURE. COMMON CAUSES OF HEART FAILURE INCLUDE CORONARY ARTERY DISEASE INCLUDING A PREVIOUS MYOCARDIAL INFARCTION (HEART ATTACK), HIGH BLOOD PRESSURE, ATRIAL FIBRILLATION, VALVULAR HEART DISEASE, EXCESS ALCOHOL USE, INFECTION, AND CARDIOMYOPATHY OF AN UNKNOWN CAUSE. THESE CAUSE HEART FAILURE BY CHANGING EITHER THE STRUCTURE OR THE FUNCTIONING OF THE HEART. THERE ARE TWO MAIN TYPES OF HEART FAILURE: HEART FAILURE DUE TO LEFT VENTRICULAR DYSFUNCTION AND HEART FAILURE WITH NORMAL EJECTION FRACTION DEPENDING ON WHETHER THE ABILITY OF THE LEFT VENTRICLE TO CONTRACT IS AFFECTED, OR THE HEART'S ABILITY TO RELAX. THE SEVERITY OF THE DISEASE IS USUALLY GRADED BY THE DEGREE OF PROBLEMS WITH EXERCISE. HEART FAILURE IS NOT THE SAME AS MYOCARDIAL INFARCTION OR CARDIAC ARREST. OTHER DISEASES THAT MAY HAVE SYMPTOMS SIMILAR TO HEART FAILURE INCLUDE OBESITY, KIDNEY FAILURE, LIVER PROBLEMS, ANEMIA, AND THYROID DISEASE. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE EXACT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED BUT MAY HAVE BEEN DUE TO PROCEDURAL FACTORS AND OR PATIENT FACTORS NOT PROVIDED. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS PER LITERATURE ARTICLE FROM JAPAN, "CHRONIC ACTIVE MYOCARDITIS AFTER TRANSAPICAL TRANSCATHETER AORTIC VALVE IMPLANTATION," HEART FAILURE DUE TO MYOCARDITIS WAS OBSERVED POST PROCEDURE. AN 87-YEAR-OLD MAN WITH SYMPTOMATIC AORTIC STENOSIS (LEFT VENTRICULAR EJECTION FRACTION [LVEF] 63%, AORTIC VALVE AREA 0.88 CM2, MEAN PRESSURE GRADIENT 26 MMHG, STROKE VOLUME INDEX 23 ML/MIN2, AGATSTON SCORE 2,781) UNDERWENT TRANSAPICAL (TA) TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) WITH SAPIEN3 TO AVOID STROKE RISK FROM AORTIC ARCH ATHEROSCLEROSIS. (VALVE SIZE AND PROCEDURE DATE ARE UNKNOWN). AFTER TAVI, TRANSTHORACIC ECHOCARDIOGRAPHY SHOWED LVEF OF 59%. SERUM TROPONIN T PEAKED AT 24 NG/L. FOUR MONTHS LATER, THE PATIENT WAS HOSPITALIZED FOR WORSENING HEART FAILURE, WITH LVEF HAVING DECREASED TO 26% AND SERUM TROPONIN T HAVING INCREASED TO 84 NG/L. CORONARY ANGIOGRAPHY SHOWED NO SIGNIFICANT CORONARY ARTERY STENOSIS. CARDIAC MAGNETIC RESONANCE IMAGING SHOWED PROLONGED MYOCARDIAL T2 RELAXATION TIME THROUGHOUT THE LEFT VENTRICLE AND LATE GADOLINIUM ENHANCEMENT AT THE TA-TAVI APPROACH SITE. 18F-FLUORODEOXYGLUCOSE (FDG) POSITRON EMISSION TOMOGRAPHY/COMPUTED TOMOGRAPHY SHOWED ABNORMAL FDG UPTAKE ONLY AT THE SAME SITE. ENDOMYOCARDIAL BIOPSY REVEALED SEVERE INFLAMMATORY CELL INFILTRATION, INTERSTITIAL FIBROSIS, AND POSITIVE TENASCIN-C IMMUNOSTAINING, SUGGESTING CHRONIC ACTIVE MYOCARDITIS. SYMPTOMS WERE RELIEVED BY GUIDELINE-DIRECTED MEDICAL THERAPY; HOWEVER, LVEF WAS NOT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331717 UNKNOWN SAPIEN 3 VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Hospitalization