Catalog Number UNK RX XPEDITION |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Myocardial Infarction (1969); Thrombosis (2100); Transient Ischemic Attack (2109)
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Event Date 03/01/2012 |
Event Type
Injury
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Manufacturer Narrative
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The other additional xience device is being 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 myocardial infarction, thrombosis, and cerebrovascular accident are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s) of myocardial infarction, transient ischemic attack, cerebrovascular accident and thrombosis, 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.The additional adverse patient effect of death is being filed under a separate medwatch report#.Article: five-year outcomes in patients with diabetes mellitus treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents.
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Event Description
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It was reported through a research article identifying xience prime and xience xpedition stents that may be related to the following: death, myocardial infraction, revascularization, coronary artery bypass surgery, transient ischemic attack, stroke, stent thrombosis.Specific patient information is documented as unknown.Details are listed in the article, titled: five-year outcomes in patients with diabetes mellitus treated with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents.
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Manufacturer Narrative
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This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.
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Search Alerts/Recalls
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