Udi: (b)(4).The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are 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 at low risk for open surgical therapy (i.E., predicted risk of surgical mortality >=1% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator).The edwards sapien 3 transcatheter heart valve, model 9600tfx, and accessories are 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 low 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 used in an off-label implantation in the mitral position.As there are no specific ifu or training materials related to mitral procedures, the available training materials were reviewed only for information potentially relevant to the device use., paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement 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.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.The patient screening manual instructs the operator on proper valve assessment, including the use of echo, aortogram and ct to appropriately measure the annulus diameter, content and distribution of calcium, and leaflet characteristics.Contraindications, important considerations when assessing the valve, and choosing the proper thv are also discussed.The thv training manuals also instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures are also included.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.With the information provided, the exact cause of the pvl is unknown but may be related to patient factors (mac).A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.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.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.
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