The manufacturer was informed of the following event through mantra study.Reportedly, perceval plus size l was implanted in the patient on (b)(6) 2023.Based on information received, patient had complete heart block with underlying ventricular escape (around 40 bpm) on (b)(6) 2023 which led to insertion of a permanent pacemaker on (b)(6) 2023.Based on the information available, patient has recovered, and the event has resolved.As reported, patient has a history of coronary artery disease, systemic hypertension, dyslipidemia, and nyha class ii.
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Updated fields: b4, g3, g6, h2, h6.The manufacturing and material records for the perceval plus heart valve and stent, model #pvf-l-us, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by a manufacture¿s quality engineering.The results confirmed that this valve 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 information available, the definitive root cause of the reported event cannot be established.However, from the document review performed, no manufacturing deficiencies with the device were noted.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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