Per the instructions for use (ifu), valve thrombosis is a potential risk associated with the use of the transcatheter heart valves (thv).Thrombosis is a rare and well-recognized complication associated with the use of bioprosthetic heart valves.Valve thrombosis is the formation of significant blood clots forming on the valve.Potential patient risk factors such as atrial fibrillation, systemic disease (e.G., systemic lupus erythematosus, inflammation and damage to various body tissues, including joints, skin, kidneys, heart, lungs, blood vessels, and brain), the valvular disease itself, and reduced cardiac ejection fraction can contribute to increased risk of thrombus/thrombosis.Sub-optimal anticoagulation during the procedure and underlying patient conditions can also result in increased thrombogenicity.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous preparation, aspiration, and flushing of the devices to prevent and/or remove clot(s).Short-term anticoagulation therapy may also be necessary after valve repair, anticoagulation is prescribed per institutional guidelines.Intra-procedural intra-cardiac thrombus and post-procedure or late valve thrombosis are complex processes triggered by the interaction between the host and the device which are highly variable among patients.It is the natural tendency of the body to form a clot on foreign objects in the vascular space and a definitive root cause cannot always be confirmed.The device training manuals instruct the operator to consider all procedural and anatomical factors.Physicians are extensively trained by edwards before they are qualified to use the device system.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals, and proctored procedures.Operators are also instructed to use fluoroscopy in conjunction with echocardiography for optimal visualization during positioning and deployment and cautions include the maintenance of the patient-s anticoagulation status (act at >250 seconds) during the procedure.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results are inconclusive due to the limited information provided; however, the event could be related to the mechanisms described above.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 this adverse event 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 monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.Remains implanted.
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Per the report received from italy via clinical study, it was a case of a 23mm sapien 3 ultra valve in the aortic position by transfemoral approach.Approximately two months after tavi procedure, the patient presented with valve thrombosis leading to heart failure with an av mean pg of 61 mmhg.As a consequence, a surgical re-intervention was performed.After surgical intervention, the patient presented with multiorgan failure and expired.
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