It is normal to have a small gradient across a prosthetic valve after implant.If elevated, it may indicate obstructed flow across the valve.An increase in gradients may result from patient factors such as hypertrophic cardiomyopathy (hcm) or sub-valvular mitral stenosis.Additionally, an increase in gradients can indicate that a leaflet is not functioning optimally due to calcification or early thrombus formation.In the instance of a bioprosthetic valve in valve implant an increased gradient can be a result of intravalvular regurgitation and is not a result of a valve leaflet malfunction.If mild, these patients will not require intervention and will be followed with serial echocardiography.If significant and results in symptoms, it may require intervention.In this case, there was no allegation or indication a device malfunction contributed to the event.The cause of the increased gradient cannot be determined.However, it is possible that it may be related to the progression of pre-existing mitral valve disease.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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As reported, approximately 2 years post valve in valve procedure in the mitral position with a 26mm sapien 3 valve in a previously implanted 27mm non-edwards surgical valve, increased gradient was noted over time after a course of anticoagulation with marginal improvements.The patient was brought back to the cath lab to fracture the non-edwards valve and fully expand the sapien 3 valve.The result was good, eliminating the gradient.The patient is stable post procedure.
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