The date of the event(s) is unknown.According to the article the date range for this event is from april 2017 to december 2019. for this reason, the first day of the range was used as the occurrence date.Per the instructions for use, paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tmvr) 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 native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.The edwards sapien 3 transcatheter heart valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.It is also indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.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 cause for the pvl post valve deployment cannot be determined.However, it may be related to patient/procedural factors.The author did not provide patient or procedural factors that could help determine a root cause of the pvl.There is no allegation or indication a device malfunction contributed to this adverse event.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.Biography: lamelas, joseph, and ahmed alnajar."early outcomes for surgical minimally invasive sapien 3 transcatheter mitral valve replacement." the annals of thoracic surgery (2020).
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