Exemption number e2016006, this report summarizes 1 event of device thrombosis for the sapien 3 ultra valve in the aortic position.The ¿time to event¿ (tte, in days) for this event was 0.The device identification (di) numbers for edwards sapien 3 ultra transcatheter heart valve are: (b)(4).Per the instructions for use (ifu), potential risks associated with the overall procedure include thrombus formation, plaque dislodgment, and embolization that may result in myocardial infarction, stroke, distal peripheral occlusion, and/or death.It is the natural tendency of the body to form clot on foreign objects in the vascular space.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous wiping and flushing of the devices to prevent and/or remove clot.The thv training manuals and ifu instruct the operator to administer heparin and maintain the act at = 250 sec.In this case, specific procedural details were not available to determine potential contributing factors.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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