B3: date of event is estimated.D4: the udi is unknown as the part/lot number was not provided.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.The reported patient effects of vascular dissection, perforation, surgical intervention, embolism / embolus, thrombosis/ thrombus, vasoconstriction, stroke, transient ischemic attack (tia), myocardial infarction (mi), unspecified tissue injury, respiratory failure, renal failure, obstruction/occlusion are listed in the emboshield nav6 instruction for use as known possible adverse events potentially associated with carotid stents and embolic protection systems.A definitive cause for the reported vascular dissection, perforation, surgical intervention, embolism / embolus, thrombosis/ thrombus, vasoconstriction, stroke, transient ischemic attack (tia), myocardial infarction (mi), unspecified tissue injury, respiratory failure, renal failure, obstruction/occlusion, unexpected medical intervention, treatment with medications, and hospitalization, 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 effect of death and malfunctions listed in the report are captured under separate medwatch report(s).
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It was reported through the pmcf (post-market clinical follow-up) report, that the emboshield nav6 embolic protection device may be related to the adverse patient effects of death, myocardial infarction, access site complications, pulmonary complications, renal complications, transient ischemic attack, stroke, thrombosis, occlusion, embolization, dissection, perforation, intervention, medication administration, amputation / surgery and re-hospitalization and device issues of unable to insert and unsuccessful placement due to difficulty removing the filter and carotid artery spasm requiring treatment.Details are listed in the attached article, titled post market clinical follow-up evaluation report abbott carotid stent and embolic protection systems.
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