Per the instructions for use (ifu), valve malposition and embolization are known potential complications associated with the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition/embolization, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, loss of pacing capture, rapid deployment and movement of the delivery system by the operator.The edwards sapien 3 transcatheter heart valve is indicated for patients with severe symptomatic calcified native aortic valve stenosis.Deployment of the sapien 3 valve in a native mitral valve is not indicated per the labeling; therefore the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario.In this case, the valve was placed too atrial in the native mitral position resulting in pvl.A second device was required.The root cause of this event remains indeterminable but was likely due to patient and procedure related factors (deployment in the native mitral annulus).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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Edwards received notification from a sales rep that during transcatheter valve replacement of a stenosed native mitral valve a 29mm sapien 3 was deployed too atrial leaking to a significant jet of mr.As reported, a lampoon procedure was done to lacerate the anterior leaflet of her mitral valve prior to valve replacement, creating severe mr.A 29 s3 with +3 cc's of volume was deployed but appeared to be too atrial in depth (a significant jet of mr was visualized on tee).A second 29 s3 with +3 cc's volume was deployed inside the first and the mr jet was resolved.However, during deployment a large pericardial effusion was visualized on tee as well.The team attempted to tap the effusion and pulled a significant amount of blood but it did not resolve the effusion.The physician opened the chest and attempted to save the patient but eventually it was decided that nothing could be done.The cause of the event was likely an injury to the atrio-ventricular (av) groove.
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