This report provides data from thv/tvt registry exemption number (b)(4) and summarizes 3 reintervention - mitral valve serious injury events for the sapien 3 transcatheter heart valve in the mitral position.The "time to event" (tte, in days) for this event was 72.67.The device identification (di) numbers for edwards sapien 3 transcatheter heart valve are: (b)(4).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 several 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 mismatch 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, there was no allegation or indication a product malfunction contributed to this adverse event.Specific clinical and procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards 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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