B3: date of event is estimated.D4: the udi is unknown as the part/lot number was not provided.D6a: date of implant is estimated.The device was not returned for evaluation.A review of the lot history record of the reported lot could not be conducted because the part and lot number was not provided.The reported patient effects of stenosis, transient ischemic attacks, stroke, myocardial infarction, occlusion are listed in the xact carotid stent system information for prescribers as adverse events potentially associated with carotid stents and embolic protection systems.A conclusive cause for the reported stenosis, transient ischemic attack, cerebrovascular accident, myocardial infarction, occlusion and tissue damage, and the relationship to the product, if any, cannot be determined.The treatments appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional patient effect of death listed in the report is captured under a separate medwatch report.Attachment, titled "post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems".
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It was reported through the pmcf (post-market clinical follow-up) report, that the xact stent may be related to the adverse patient effects of death, myocardial infarction, access site complications, transient ischemic attack, stroke, occlusion, re-stenosis, revascularization and re-hospitalization.Details are listed in the attached article, titled post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems.Please see the attached post market clinical follow up evaluation report for specific information.
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