Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 the distal part of the stent did not be deployed well.However, the distal part of the stent did not be deployed in the end and it seemed that the stent edge was bent while the stent could cover whole the neck of the aneurysm.Additional information was not provided after 3 gfe attempts.It is most likely that anatomical factors contributed to the reported event, but this cannot be conclusively determined.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
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