This event was captured based on literature review.It was reported through a research article identifying xience v stents and promus stent that may be related to the following: all-cause death, myocardial infarction, revascularization (restenosis), major bleeding, acute renal failure, stroke and stent thrombosis.Specific patient information is documented as unknown.Details are listed in the attached article.
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(b)(4).Date of event estimated as date of publication.The reported patient effects of hemorrhage, myocardial infarction, renal failure, thrombosis, and restenosis, as listed in the promus everolimus eluting coronary stent system instructions for use are known patient effects that may be associated with the used of the device.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.You are receiving this mdr report from abbott vascular because boston scientific corporation distributes promus as its own brand labeling of abbott vasculars drug eluting stent in the us.The xience is being filed under a separate medwatch report.The additional adverse patient effect of death is being filed under a separate medwatch report.
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