Per the instructions for use (ifu), valve malposition requiring intervention is a known potential complication associated with the transcatheter valve replacement (tvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to ventricular malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, minimally or bulky/severely calcified leaflets, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In patients with high-risk anatomical features for ventricular malposition, balloon valvuloplasty may provide indication of potential balloon movement during valve deployment. per the instructions for use (ifu), paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) procedure.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the valve annulus, uneven distribution of calcium on the valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.In this case, there was no allegation or indication a product deficiency malfunction contributed to this adverse event. the cause of the too ventricular, canted/tilted malposition is unknown, however, may be related to procedural factors (valve ¿jumped¿). the cause of the pvl is most likely related to the initial valve malposition and possibly patient factors.The cause of the embolization is unknown, however may be due to the initial malposition of the valve being too ventricular. 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.No corrective or preventative actions are required.
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As reported from our affiliates in (b)(6), during tavr valve in valve procedure with a 20mm sapien 3 valve inside a 21mm mitroflow surgical valve via transfemoral approach, the valve ¿jumped¿ and landed towards the bottom of the left ventricle. the valve was brought back into the mitroflow valve with the balloon of the transcatheter delivery system, where it was deployed.The resulting position was not as optimal as the physicians intended due to the previous circumstances.The valve was more ventricular, it was canted/tilted, however seemed well anchored. a post dilation was performed.The patient was hemodynamically stable with mild-mod pvl at the end of the procedure. the following morning, an x-ray and echo revealed that the thv valve had embolized into the ventricle. the patient was immediately brought to the or where the sapien 3 valve was extracted and replaced by a surgical aortic valve. the patient is stable and recovering from surgery.
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