It was reported patients with complex bifurcation lesions had optical coherence tomography (oct)-guided percutaneous coronary intervention (pci) or angiography-guided pci.The primary end point was a composite of major adverse cardiac events (mace), defined as death from a cardiac cause, target-lesion myocardial infarction, or ischemia-driven target-lesion revascularization at a median follow-up of 2 years.The xience everolimus-eluting stent was prespecified for implantation.The article identified xience drug-eluting stents that may be related to stent malposition, patient deaths, myocardial infarction, ischemia, stent thrombosis, target vessel revascularization, re-hospitalization.The article's supplemental appendix mentioned ventricular tachycardia (vt), ventricular fibrillation (vf), cardiogenic shock, major bleeding, stroke, vessel occlusion, perforation, and dissection as procedure related complications; coronary artery bypass graft revascularization was also noted.The supplemental appendix also listed the following procedural related complications during oct guided pci, vt/vf, cardiogenic shock, major bleeding, stroke, vessel occlusion, perforation, dissection and death.Contrast-associated acute kidney injury without an oct/dragonfly malfunction was mentioned during oct guided pci.The article concluded; oct-guided pci had a lower incidence of mace at 2 years than angiography-guided pci.Details are listed in the attached article, titled ¿oct or angiography guidance for pci in complex bifurcation lesions.".
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D4: the udi number is not known as the catalogue number was not provided.The device was not returned for analysis.A review of the electronic lot history record (elhr) and the lot level similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment(s) appears to be related to the operational context of the procedure.The reported patient effects of myocardial infarction, ischemia, stenosis, tachycardia, ventricular fibrillation, bleeding complications (hemorrhage/blood loss/bleeding), stroke, thrombosis, perforation and dissection are listed in the xience v everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional patient effect of death reported in the article is captured under a separate medwatch report.
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