Age - average.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 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 stroke, transient ischemic attack (tia), and myocardial infarction (mi) are listed in the rx accunet instructions for use (ifu) as known potential patients effects associated with the use of the device.Based on the information reported through the pmcf report, a definitive cause for the reported difficulty to insert and activation failure could not be determined.Additionally, a conclusive cause for the reported patient effects, 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 patient effect of death 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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It was reported through the post market clinical follow-up (pmcf) report, that the accunet embolic protection device may be related to the adverse patient effects of death, myocardial infarction, transient ischemic attack, stroke, and the device issues of unable to insert and unsuccessful placement.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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