This is one of four manufacturer reports being submitted for this article.There is no indication of valve explant nor device return.The dates of the events are unknown; however, according to the article the study period was from december 2014 and october 2015.For this reason, the first day of the reported study period (b)(6) 2014 was used as the occurrence date.Per the instructions for use (ifu), conduction system defects (heart block), arrhythmias, and conduction system defects, (bradycardia, lbbb, rbbb) which may or may not require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, the use of local and/or general anesthesia, bioprosthetic heart valves, and the thv procedure.Sick sinus syndrome (sss), also called sinus node dysfunction (snd), is an umbrella term for a group of abnormal heart rhythms (arrhythmias) presumably caused by a malfunction of the sinus node, the heart's primary pacemaker.Bradycardia-tachycardia syndrome is a variant of sick sinus syndrome in which slow arrhythmias and fast arrhythmias alternate.It is often associated with ischemic heart disease and valvular lesions.Sick sinus syndrome is more common in elderly adults, where the cause is often a non-specific, scar-like degeneration of the cardiac conduction system.Coronary artery disease, high blood pressure, and aortic and mitral valve diseases may be associated with sick sinus syndrome, although this association may only be incidental.Acquired snd may occur after damage to the sn artery during cardiac surgery or may be due to occlusion, such as after myocardial infarction.Another surgical cause of snd includes sn tissue damage during cannulation of the superior vena cava (svc) for cardiopulmonary bypass or extracorporeal membrane oxygenation (ecmo).Ischemic cardiac arrest may also cause snd.The natural history of snd may be highly variable, although it tends to be progressive.The only effective treatment for patients with chronic symptomatic snd is pacemaker therapy.Per the instructions for use (ifu), heart failure is a known potential adverse event associated with the thv procedure and the use of the edwards thv 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.Investigation results are inconclusive as no relevant patient or procedural factors were provided, however may be related to the mechanism above.A review of edwards lifesciences risk management documentation was performed for this case.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.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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.No corrective or preventative actions are required.Article reference: wienemann, hendrik et al.''contemporary treatment of mitral valve disease with transcatheter mitral valve implantation.'' clinical research in cardiology: official journal of the german cardiac society, 10.1007/s00392-022-02095-y.15 sep.2022, doi:10.1007/s00392-022-02095-y.No indication of explant.
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