It was reported through a research article identifying xience alpine and multilink vision that may be related to the following: patient thrombosis, dissection, malapposition, revascularization, and rehospitalization.This article summarizes clinical outcomes of 42 patients that were treated with xience alpine stents and 21 patients that were treated with multilink vision stents.Specific patient information is documented as unknown.Details are listed in the attached article, titled "comparison of the vessel healing process after everolimus-eluting stent and bare metal stent implantations in patients with st-elevation myocardial infarction.".
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B3/d6: dates estimated.B5: the adverse patient effects referenced in b5 will be filed under a separate medwatch report #.B5: the additional device referenced in b5 is being filed under a separate medwatch report #.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 lot and part number were not provided.A conclusive cause for the reported patient-device incompatibility could not be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The udi is unknown as the part and lot numbers were not provided.Article title: comparison of the vessel healing process after everolimus-eluting stent and bare metal stent implantations in patients with st-elevation myocardial infarctionna.
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