The device was not returned for analysis as it was implanted in the patient.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.Inflammation and thrombosis formation are known inherent risk of endovascular procedure and are documented in the pipeline instruction for use.Based on the reported information, there was no allegation that a malfunction or deficiency of the device occurred during the procedure.There is no evidence suggesting that the device was defective, but rather a post procedure and patient condition related event.However, the exact cause remains unknown.If information is provided in the future, a supplemental report will be issued.
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Medtronic received report that post pipeline embolization procedure, the patient developed inflammation due to thrombus not mass effect.It was determined the symptom were not related to the device or the flow diverter treatment.The issue was not critical, and the patient was confirmed to have recovered approximately 5 months post intervention.The cerebral aneurysm was reported to have been 25mm.
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