Medtronic received a report that the patient died due to hemorrhaging from dissection following a procedure where a marksman microcatheter had been used.It was reported that the patient developed cerebral infarction associated with middle cerebral artery (m1) occlusion and was transferred to the hospital.The concomitant devices used were a guidewire, guide catheter, microcatheter (marksman), and balloon catheter.The microcatheter lowered was to the guide catheter position.An attempt was made to remove the thrombus by deploying the embotrap thrombi removal device in the occluded site; however, the arteriosclerosis was severe and there was strong resistance.Because the thrombus could not be removed with the embotrap alone, the microcatheter was raised to the point near the thrombus and the thrombus was collected.Embotraps were deployed three times in total; however, the distal side of the thrombus could not be removed, so thro mbi removal was performed using another company's device.Subsequently, dissection occurred on the distal side of the thrombus, and hemorrhaging was observed.Subsequently, hemostasis could not be achieved and the procedure could not be continued.The patient died after surgery.The attending physician stated that the event was not caused by a problem with the product itself, but rather from the patient's background (severe arteriosclerosis) and the progress until the start of treatment, the situation might have been quite severe.Hemorrhaging due to dissection led to death.The patient was undergoing treatment for acute cerebral infarction.The patient's vessel tortuosity was strong.The access vessel was the middle cerebral artery, which was 2.3mm in diameter.The device was prepared and flushed as indicated in the instructions for use (ifu).
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