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Catalog Number AP28 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intracranial Hemorrhage (1891)
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Event Date 03/23/2022 |
Event Type
Death
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Manufacturer Narrative
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The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, 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, hydrocephalus, hematoma or hemorrhage at the site, intraventricular hemorrhage, re-bleeding, thromboembolic events, including death.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Event Description
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On 23-mar-2021, the patient underwent a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using artemis neuro evacuation device.There were no procedural complications reported.On (b)(6) 2021, the patient¿s post-procedure computed tomography (ct) scan revealed intraventricular hemorrhage (ivh) in the bilateral frontal horns, thalamic ich, and right sylvian subarachnoid hemorrhage (sah).On (b)(6) 2021, a follow up ct head scan demonstrated stable residual ivh.On (b)(6) 2021, upon usage of external ventricular drain (evd), a ct scan showed redemonstration of blood products along the route of a previous ventriculostomy catheter.Blood products adjacent to the left thalamus and a small volume of ivh of the left occipital horn were also found.On (b)(6) 2021, after the index procedure, the patient improved and was medically and neurosurgically cleared for discharge to acute nursing rehabilitation with plans to continue lovenox (enoxaparin) to coumadin bridge.On (b)(6) 2021, the patient was found to be in respiratory distress with sepsis and septic shock.The patient was intubated, treated with vasopressors and antibiotics, and a ct head was suggestive for massive hemorrhages in new locations.On (b)(6) 2021, the patient remained comatose and did not make significant neurological recovery, and the family elected terminal extubation.The patient's death was reported to be unrelated to the artemis and related to comorbidities.The extension of prior bleeding was reported to be a serious adverse event unrelated to the artemis with a possible relationship to the procedure.The event was considered unresolved at the time of study exit.On 20-may-2022, additional information indicated that the clinical events committee (cec) adjudicated the extension of prior bleeding to be a serious adverse event related to the artemis, the index ich and index procedure and unrelated to the comorbidity.
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Search Alerts/Recalls
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