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.The reported patient effect of anuerysm is listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.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 a de novo, moderately calcified, and mildly tortuous vessel in the left circumflex (lcx).On (b)(6) 2022 pre-dilatation was performed using a 2.0x8mm semi compliant balloon at 10 atmospheres (atms) and the 3.0x18mm xience v stent was deployed and implanted.Post dilatation was performed with a 3.0x10mm non-compliant balloon, no residual stenosis and no dissection noted.On (b)(6)2022, patient came for elective percutaneous coronary intervention (pci) to the left anterior descending (lad) artery and when angiography was performed it was noticed that the lcx had an aneurysm in and around the xience v stent implanted on (b)(6) 2022.Reason for the aneurysm was unknown, however, in the physician's opinion, the xience v must have caused the aneurysm.There was no treatment or intervention to treat the aneurysm.The patient was kept on medical management.There was no clinically significant delay in the procedure.No additional information was provided.
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