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.It was reported that the subject stent twisted (bow-tied in the mid portion of the stent) upon deployment.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, the anatomy was tortuous, a microcatheter was used to deploy the device, no excessive force was applied at any point while advancing the stent within the microcatheter, and the stent size was appropriate for the treatment site.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 was assigned to this complaint.H3 other text : device is not available for evaluation.
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