Per the instructions for use (ifu), conduction system defects (heart block), arrhythmias and conduction system defects that may require a permanent pacemaker are potential adverse events associated with balloon aortic valvuloplasty, bioprosthetic heart valves, and the thv procedure.According to the valve academic research consortium (varc) guidelines, the close anatomical relationship between the aortic valve complex and the branching atrioventricular bundle may explain these complications of the thv procedure.According to the literature review, and as documented in ew clinical technical summary for complaints-conduction disturbances/ heart block, atrioventricular conduction disturbances after thv are associated with many patient related and procedural related factors, including pre-operative co-morbid status, the degree, and bulkiness of aortic valve and annular calcification, inter-ventricular septal thickness, pre-existing electrocardiogram abnormalities, the depth of prosthesis implantation, and the profile of the implanted prosthesis.Unlike conventional avr, where there may be localized trauma due to decalcification of the annulus and/or suture placement in the proximity of the av node or the bundles, thv may cause conduction abnormalities through mechanical impingement of the conduction system by the prosthesis.The mechanisms of the development of heart block after thv are well documented and described in the literature.It is also documented that pre-existing heart block is common in patients undergoing thv or surgical avr and another 4-6 % will develop postoperative heart block, potentially requiring a permanent pacemaker.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that patient factors not provided may have caused or contributed to the event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.For index procedure events: 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 monthly, 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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As reported by the benchmark clinical study, during a transfemoral tavr procedure with a 23mm sapien 3 ultra valve, the patient developed left bundle branch block with transient av block.Approximately 1 day post tavr, a permanent pacemaker was implanted due to persistent lbbb, and 1st degree av block with paroxysms of complete av block.The event was resolved.
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