The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.The reported patient effect of arrhythmia is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat mildly calcified, 95% stenosed lesions in the left anterior descending (lad), right coronary (rca) and diagonal (left coronary) arteries.On (b)(6) 2023, the patient had 7 xience skypoint drug eluting stents (des) implanted without issue.A 4.5x33mm and 4.5x18mm stents were placed in the rca.A 3.0x38mm, 3.5x38mm and 3.5x8mm stents were placed in the lad.A 2.5x18mm and 2.5x8mm stents were placed in the diagonal artery.On (b)(6)2023, the patient presented to a different physician experiencing constant arrhythmias throughout the day and bradycardia with heart rates of 32-35 beats per minute (bpm).The patient was asymptomatic prior to his procedure on 3/24/2023.Additional treatment has not yet been provided.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
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