B2: date of death is estimated.B3: date of event is estimated.D4: the udi is unknown as the part/lot number was not provided.D6: 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 effect of death is listed in the xact carotid stent system information for prescribers 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 additional patient effects listed in the report are captured under a separate medwatch report.
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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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