The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, non conformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the artemis neuro evacuation device include, but are not limited to, hematoma or hemorrhage at the site, intraventricular hemorrhage, re-bleeding, thromboembolic events, including death.Therefore, it was determined that the reported adverse events were anticipated complications.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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On (b)(6) 2019, the patient underwent a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis).Following the procedure, a computed tomography scan (ct scan) showed a re-hemorrhage of 8 cc in volume into the tissue bed with mass effect, midline shift and, right uncal herniation.The re-hemorrhage was treated with standard medical management.The patient was discharged to a rehabilitation center on (b)(6) 2019 in stable condition and no medications, blood transfusion and medical procedure were required to address the re-hemorrhage into the tissue bed.The re-hemorrhage into the tissue bed was adjudicated to be a serious adverse event related to the artemis, the index ich, the index procedure, and to the comorbidity.
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