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) 2024.Based on information received, patient had chb with afib on (b)(6) 2024.The patient needed a permanent pacemaker which was implanted on (b)(6) 2024 to resolve the issue.As reported, the patient's clinical history included coronary artery disease; arrhythmia: afib; systemic hypertension; diabetes mellitus: type ii, insulin dependent; dyslipidemia; renal insufficiency / renal disorder (dialysis ongoing); percutaneous coronary intervention (stenting 2019); and was in nyha class iii.Based on the information available, prior and concomitant anticoagulant/antiplatelet medications are warfarin, eliquis and aspirin.
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