As reported by a field clinical specialist, a 29 mm sapien xt was implanted in the mitral position via transfemoral approach.Five years post implant the patient presented with shortness of breath and fatigue. work up showed that 2 of the 3 leaflets of the xt valve were not functioning, causing stenosis.The gradient was 25 mmhg by echocardiogram and 10 mmhg by cath. a 29 mm sapien 3 valve was prepped and implanted valve in valve (viv).Post deployment, the stenosis was resolved and the gradient was reduced to 3 mmhg.The patient was discharged in stable condition.Per medical, opinion, the stenosis was not due to an early device failure, but rather the patient being "young and very sick." in addition, 2 of the 3 leaflets were not functioning.The cause of this was normal wear and tear for the age of the valve and the condition of the patient.
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Udi: (b)(4).The valve remains implanted in the patient.Stenosis of an implanted valve may be a manifestation of structural valve deterioration (svd).This term refers to changes intrinsic to the valve, and can include failure modes such as wear, calcification, leaflet tear, stent creep, leaflet disruption, or leaflet retraction.There are cases of svd that result in a combination of regurgitation and stenosis.It may be mild and not require any intervention or it may be moderate to severe.In these cases, it causes the heart to work harder to eject blood from the ventricle.Depending on severity it could be an indication for valve replacement or medical intervention.A very common failure mode is tissue calcification.The mechanisms for bioprosthetic heart valve tissue calcification are not fully understood.Many factors can contribute to the onset and propagation of calcification including patient related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It is widely understood that patients with chronic renal disease and prior history of calcific stenosis of the native valve may be predisposed to bioprosthetic calcification.In this case the cause of the stenosis is unknown as patient information was requested but not forthcoming.However, per medical opinion, ¿the stenosis was not due to an early device failure, but rather the patient being "young and very sick." complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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