D4 lot number - corrected from 2314020 to 23140420.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that during an flow diverter case the physician was not satisfied with the distal end of flow diverter.The physician used a balloon the fix the distal end of the stent.Following the ballooning an angiogram was performed and a bleed was noticed.The physician used coils to stop the bleed.The reported patient intracranial hemorrhage is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to the as reported patient intracranial hemorrhage.Should the device became available in the future, the parent record and investigation will be reopened and addressed accordingly.
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