The device was not returned as it was successfully implanted in the patient.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.Thrombus formation is a known inherent risk of the endovascular procedures and is documented in our devices¿ instructions for use (ifu).Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the pipeline device occurred during the treatment procedure.There is no evidence suggesting that the device was defective, but rather a post procedure and patient condition related event.The exact cause is remains unknown.If information is provided in the future, a supplemental report will be issued.
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