Per the instructions for use (ifu), 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 the transcatheter aortic valve replacement (tavr) procedure.There are several potential etiologies for ventricular perforation during a tavr 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 the sapien 3 transcatheter heart valve (thv).Training includes proper guidewire positioning, fixation of the tvp to prevent ventricle perforation, and careful manipulation of devices.Per the procedure didactic, patients with small ventricles are at particularly high risk for ventricular perforation.In this case, there was no allegation or indication a device malfunction contributed to this adverse event. investigation results suggest/indicate the guidewire perforated through the ventricle while the delivery system was being advanced.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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As reported by an edwards lifesciences affiliate in (b)(6), during a transfemoral tavr for aortic position, while advancing the delivery system over the aortic arch, the systolic blood pressure dropped to 20-30¿s mmhg and pericardial effusion increased.A 23mm sapien 3 was immediately deployed in addition to introduce percutaneous cardiopulmonary support (pcps).Drainage was performed and the chest was opened to arrest the bleeding.Hemostasis was achieved and the pcps was removed on leaving the operating room.Upon reviewing the cine images, it was determined to be a guidewire perforation because the wire appeared to protrude the left ventricle while advancing the delivery system.
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