The manufacturing and material records for the perceval heart valve, model#: icv1209, s/n#: (b)(6), as they pertain to the reported event, were retrieved and reviewed by quality engineering at livanova canada corp.The results confirmed that this valve satisfied all material, visual, and performance standards required for a (model#: icv1209) perceval heart valve at the time of manufacture and release.As the device was not received for analysis, no device investigation can be performed and the root cause of the event cannot be determined.However, based on the document review performed, no manufacturing deficiencies were identified.Conduction disorders are common in patients with aortic valve diseases.As a result, it is common for patients to receive permanent pacemaker implantation after aortic valve replacement.Risk factors include preexisting conducting disease and preoperative aortic regurgitation.This event is, therefore, a known, inherent risk of the procedure, and it is listed among the potential adverse events in the perceval ifu.
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