Lot/serial no.: unknown.The neurovascular stryker surpass evolve device is not currently approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (pma # p170024).See section 4.11.3 guidance for industry and food and drug administration staff, november 8, 2016.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Based on the information currently available the reported right sided weakness (neurological deficit), thrombosis and transient ischemic attack are known and anticipated complication to these types of procedures and patient condition, and is listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complications has been assigned to the reported event.The device remains implanted in patient.
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