The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 event is anticipated in nature as per the product dfu.An assignable cause of anticipated procedural complication, will be assigned to the reported event, as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.Device remains in patient.
|
It was reported that approximately 2 month-post successful procedure of an aneurysm located on the right middle cerebral artery (mca) with 2 stents (subject device) , at the main branch (trifurcation), the patient experienced diarrhea and urinary tract infection that was treated.Just after, the patient died.Sudden death is of unknown etiology.
|