H4 manufacturing date ¿ added.D4 expiration date - added.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 event occurred post-treatment of a non-target right pericallosal artery aneurysm with two subject stents and non-stryker coils.There was no indication that the stent device contributed to the reported aneurysm rupture.The patient aneurysm rupture reported in this investigation is listed as known complication in the device directions for use (dfu).The reported event is known and an anticipated complication to these types of procedures and patient condition, and are listed as such in the device dfu, therefore an assignable cause classification of anticipated procedural complication will be assigned to this complaint.H3 other text : device remains implanted in patient.
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