As reported by the field clinical specialist (fcs), during a tmvr procedure with a 26mm sapien 3 ultra valve, the patient came back with significant paravalvular leak (pvl) with dyspnea and fatigue.The patient was treated with post dilation using 26 mm commander delivery system.The patient was stable after post dilation.There were no allegations of an edwards device malfunction.
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Correction to h6 based on additional information.The complaint for paravalvular leak was unable to be confirmed due to unavailability of medical record/procedural imagery.A review of the device history record (dhr) review revealed no indication that a manufacturing non-conformance contributed to the complaint.A review of instructions for use (ifu)/training materials revealed no deficiencies.It should be noted that the thv was implanted in native mitral position with mitral annular calcification (mac) for this case.The sapien 3 ultra resilia (s3ur) with the commander delivery system (ds) was indicated for native aortic valve, surgical and transcatheter bioprosthesis aortic valve, surgical bioprosthesis mitral valve and native mitral valve with an annular plasty ring replacement only.So, it was considered an off-label operation.Per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement procedure.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the cardiac tissue, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post-deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.The mechanism behind worsening pvl, as reported in this case, is not well understood but may be related to cardiac remodeling.As reported, 'during a tmvr procedure with a 26mm sapien 3 ultra valve, the patient came back with significant paravalvular leak (pvl) with dyspnea and fatigue.The patient was treated with post dilation using 26 mm commander delivery system.The patient was stable after post dilation'.In this case, post-dilation was performed, which indicated deployed valve under expanded.In additional, implanting valve in native mitral annulus could be challenging due to the bicuspid leaflets with non-circular shape of native mitral annulus, which could potentially prevent the pvl skirt to seal against the target site (native annulus), and also restricted valve expansion resulting in paravalvular leak.As such, available information suggests that procedural factors (under expanded valve, off label operation) may have contributed to the complaint 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.
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