This report provides data from thv/tvt registry exemption number (b)(4) and summarizes 1 cardiac perforation serious injury event for the sapien 3 transcatheter heart valve in the mitral position.The "time to event" (tte, in days) for this event was 0.0.The device identification (di) numbers for edwards commander delivery system are: 00690103193930, 00690103193947, 00690103193954, 00690103193961.Per the instructions for use, cardiovascular injuries, including perforation or dissection of vessels, ventricle, myocardium, or valvular structures, are potential adverse events associated with standard cardiac catheterization, balloon valvuloplasty and transcatheter heart valve (thv) procedures.There are several potential etiologies for cardiac perforation during a thv procedure, including perforation by the guidewire, the delivery system, or the transvenous pacer (tvp) lead.Physicians are extensively trained by edwards before they are qualified to use transcatheter heart valves.Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.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.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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