As reported by our affiliates in (b)(4), per the literature article "subacute mitral valve dysfunction after transcatheter aortic and mitral valve replacements", an overhanging native mitral leaflet was precluding appropriate closing of the sapien xt valve, resulting in central mitral regurgitation, and a second valve was implanted.A patient with a history of previous surgical aortic valve replacement, severely calcified degenerative mitral stenosis and moderate degenerative mitral regurgitation underwent concomitant valve-in-valve tavr combined with tmvr through a transapical approach.A 23mm sapien xt valve was successfully deployed inside the sorin mitroflow 21-mm valve in the aortic position.Then a 29mm sapien xt valve was deployed in the much calcified native mitral valve.Postprocedural transesophageal echocardiography showed mild to moderate paravalvular leak, no central mitral regurgitation (mr), no significant gradient across the new valve, and no left ventricular outflow tract obstruction.Three hours later, the patient developed severe cardiogenic shock as a result of a tmvr leaflet malfunction, leading to the new onset of severe central mr.The heart team elected to proceed with an urgent mitral valve-in-valve replacement with another 29mm sapien xt valve through the same transapical access.Immediate resolution of the central mr led to major improvement of the hemodynamic parameters and weaning of vasopressors.Thirteen days later, cardiac magnetic resonance imaging was performed and showed mild to moderate paravalvular regurgitation without any central mr.Clinical progress was favorable, and the patient was discharged home on postoperative day 15.In retrospect, an overhanging native mitral leaflet was seen to preclude the appropriate closing of the tmvr.This was probably caused by the relatively high auricular position of the first transcatheter mitral valve.Deployment of a second transcatheter valve in a more ventricular position resolved the acute mitral regurgitation by preventing protrusion of the calcified native anterior mitral leaflet underneath the mitral transcatheter valve.The initial peri-procedural success mitigates the possibility of a transcatheter leaflet damage or a disruption of the native mitral leaflets after balloon valvuloplasty.Reference: poulin a, bernier m, rodes-cabau j, doyle d, paradis jm.Subacute mitral valve dysfunction after transcatheter aortic and mitral valve replacements.The journal of thoracic and cardiovascular surgery.2018 jun 1;155(6):e167-72.
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(b)(4).The edwards sapien xt transcatheter heart valve is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic or mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.E., predicted risk of surgical mortality = 8% at 30 days, based on the sts risk score and other clinical co-morbidities unmeasured by the sts risk calculator).The device was not available for evaluation, as it remains implanted in the patient.Per the instructions for use (ifu), valve malposition requiring intervention and central regurgitation are known potential complication associated with bioprosthetic heart valves.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.There are multiple patient and procedural factors that alone or in combination can cause or contribute to central regurgitation including malposition of the valve, impingement of a leaflet due to the guide wire, over inflation of the deployment balloon, post dilation of the implanted valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.The patient screening manual instructs the operator on proper native valve leaflet assessment, taking into consideration the length, bulkiness and distribution of calcium on the native leaflets to determine whether valve performance will be impaired.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 (i.E.Minimal leaflet calcification).During the manufacturing process, all sapien valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.In this case, there was no indication a product deficiency contributed to this adverse event.Per the authors, the valve was placed too atrial and an overhanging native mitral leaflet was precluding appropriate closing of the valve, resulting in mitral regurgitation.The cause for the too atrial valve placement could not be determined with the available information.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.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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