The study investigated vascular response occurring at 3 months after xience prime and xience xpedition everolimus-eluting cobalt-chromium stent implantation in patients with st-segment elevation myocardial infarction versus stable coronary artery disease.The following complications were noted: uncovered stent struts and mal-apposed stent struts related to intrastent thrombus, irregular protrusion and edge dissection.Specific patient information is documented as unknown as this is from an article summary.Details are listed in the article, titled "vascular response occurring at 3 months after everolimus-eluting cobalt¿chromium stent implantation in patients with st-segment elevation myocardial infarction vs.Stable coronary artery disease".
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Article, titled "vascular response occurring at 3 months after everolimus-eluting cobalt¿chromium stent implantation in patients with st-segment elevation myocardial infarction vs.Stable coronary artery disease".The date of occurrence will be estimated as (b)(6) 2015.The udi number is ¿ni¿ as the catalog number was not provided.The xience prime referenced is filed under a separate medwatch report number.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effects of thrombosis and dissection are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.Based on the information reviewed, a conclusive cause for the reported wall apposition and patient effects could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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