MAUDE Adverse Event Report: PENUMBRA, INC. ARTEMIS NEURO EVACUATION DEVICE; GWG

Catalog Number	AP28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	03/23/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14692161
• Report Number: 3005168196-2022-00292
• Device Sequence Number: 5327356
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 814548017877
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2022
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2022
• Device Catalogue Number: AP28
• Device Lot Number: C24777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005