Mitral valve re-intervention in the follow-up period (in the absence of prosthetic cardiac valve thrombosis) will typically result from on-going or worsening regurgitation, valve degeneration related to the formation of calcification or pannus, or valve migration.These events are identified in the product instructions for use (ifu) as potential risks associated with the use of the thv.Regurgitation which develops progressively over time can be due to a number of issues including patient related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Calcification is a well-recognized failure mode of bioprosthetic valves.The mechanism of calcification of biomaterials is not completely understood, but is probably related to an inability of the non-viable cells to maintain their normally low intracellular concentration of calcium.Another potential condition that may lead to re-intervention is patient prosthesis mis-match and/or under-expanded valves due to thv restriction from the existing valve frame.Incorrect bioprosthetic valve sizing, and incomplete frame expansion, can contribute to valve migration.In this case, specific procedural details are not available to determine potential contributing factors, or if the event is related to an edwards device.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 at this time.This event was previously reported under 2015691-2020-12813.The device identification (di) numbers for edwards sapien 3 transcatheter heart valve are: (b)(4).
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