The manufacturing and material records for the perceval plus heart valve and nitinol stent, model pvf-l, s/n # b22113, as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve and its component satisfied all material, visual, and performance standards required for a model pvf-l perceval plus heart valve at the time of manufacture and release.Based on the available information and since the device was not accessible for testing, it is not possible to draw a definitive root cause on the reported event.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 plus ifu.
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The manufacturer was informed of the following event through mantra study.Based on the information received, a perceval plus sutureless aortic heart valve size l was implanted in the patient through mini sternotomy on (b)(6) 2023.No concomitant procedure was performed.Reportedly, as of (b)(6) 2023, there was a complete heart block requiring permanent pacemaker to be implanted on (b)(6) 2023to resolve the event.Reportedly, tvp placement was also performed on (b)(6) 2023.As indicated in the study database, patient had a history of infective endocarditis which was resolved; congenital septal defect, heart murmur, bicuspid av, av stenosis, and nyha class ii.
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