Date of event - estimated.The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Date of implant - estimated.The devices were not returned for analysis.A review of the lot history records and complaint histories could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported wall apposition; however, factors that may contribute difficulty to deploy (wall apposition) include but are not limited to incorrect device size for lesion, patient anatomical morphology, patient disease state and insufficient post-dilation.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The adverse patient effects referenced and in the attached article is filed under another mfr report number.
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It was reported through a research article identifying xience family stents that may be related to the following: thrombosis, plaque prolapse, dissection and malapposition of the stent.This article summarizes clinical outcomes of 52 patients that were treated with unspecified xience family stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "early vascular responses to everolimus eluting cobalt¿chromium stent in the culprit lesions of st elevation myocardial infarction: results from a multicenter prospective optical coherence tomography study (mechanism ami 2 week follow up study)".
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