The time to event [tte in days] for this event was 0.The device identification (di) numbers for edwards esheath introducer set are (b)(4).The instructions for use (ifu) list hemorrhage requiring transfusion or intervention as a potential risk associated with the overall tavr procedure, including potential access complications associated with standard cardiac catheterization.The majority of transfemoral access related bleeding complications are related to diseased ileo-femoral vessels and/or procedural technique during the insertion or removal of the sheath and/or dilators.There are cases where the bleeding is significant and more complex intervention or transfusion is required to treat/prevent a permanent injury from occurring.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the valve can be delivered transfemorally.In this case, specific procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards device; however, a transfusion of 2 units or more of blood was reported in the registry.By varc definition, the meet criteria for major vascular complication; therefore, the event is being reported.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.
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