Catalog Number UNK XIENCE V |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100); Stenosis (2263)
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Event Date 11/30/2006 |
Event Type
Injury
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Manufacturer Narrative
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Age: median age.Sex: majority.The device was implanted and will not return.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional patient effects and xience devices are being filed under separate medwatch reports.Literature attached: ¿everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials.¿ (b)(4).
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Event Description
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It was reported through a research article that the absorb scaffold and the xience v, xience prime, and xience xpedition stents may be related to thrombosis, target lesion failure (cardiac death, target vessel myocardial infarction, ischemia driven target lesion revascularization), myocardial infarction, death, and in device late lumen loss.Specific patient information is documented as unknown.Details provided in the attached article titled: " everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a meta-analysis of randomised controlled trials¿.
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Manufacturer Narrative
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The udi is unknown because the part number and lot number were not provided.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.It should be noted that the reported patient effect(s) of stenosis, ischemia, myocardial infarction, and thrombosis are listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures.A conclusive cause for the reported patient effect(s) of stenosis, ischemia, myocardial infarction 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.
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Search Alerts/Recalls
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