The manufacturer was informed of the following event through mantra study database.Reportedly, a perceval plus valve size xl was implanted in the patient on (b)(6) 2023.Based on the information available, patient had junctional / conversion pauses following atrial fibrillation that started on (b)(6) 2023.As such, a permanent pacemaker was implanted on the same day to resolve the event.The event severity was considered moderate.As reported, the patient's clinical history included systemic hypertension; dyslipidemia; laa thrombus; peptic ulcer disease; 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-xl-us, s/n # (b)(6), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a model # pvf-xl-us perceval plus heart valve at the time of manufacture and release.Since the device remained implanted, no further investigation on the device could be performed.However, from the document review performed, no manufacturing deficiencies 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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