It was reported through the post market clinical follow-up (pmcf) report, that the xact stent may be related to the adverse patient effects of death, myocardial infarction, access site complications, transient ischemic attack, stroke, re-stenosis, occlusion, revascularization and re-hospitalization.Details are listed in the attached pmcf, titled post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems.Please see the attached pmcf evaluation report for specific information.
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Age - average date of death - estimated date of event ¿ estimated the unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant ¿ estimated.The device was not returned for evaluation.A review of the lot history record could not be conducted because the part and lot number was not provided.The reported patient effect of death is listed in the xact carotid stent system instructions for use (ifu) as an adverse event potentially associated with carotid stents and embolic protection systems: a conclusive cause for the reported death 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 other patient effects and the other adverse events reported in the pmcf are filed under separate medwatch report numbers.Attachment: title ¿post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems.''.
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