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

Model Number	AP28-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Potential adverse events in the labeling with the artemis neuro evacuation device include, but are not limited to, hematoma expansion, intraventricular hemorrhage, hydrocephalous, including death.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
On (b)(6) 2021, the patient underwent a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using artemis neuro evacuation device (artemis).On (b)(6) 2021, the computed tomography (ct) scan revealed an interval increase in size of right basal ganglia hematoma and increased associated mass effect compared to the (b)(6) 2021 exam, with suspected interval rebleeding.It should be noted that a follow-up ct scan was done on (b)(6) 2021 and the interval rebleeding was resolved.Increase in size of right basal ganglia hematoma was reported to be an adverse event with a possible relationship to the artemis and index procedure.
Event or Problem Description
On (b)(6) 2021, the patient underwent a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using artemis neuro evacuation device (artemis).On 18-may-2021, the computed tomography (ct) scan revealed an interval increase in size of right basal ganglia hematoma and increased associated mass effect compared to the (b)(6) 2021 exam, with suspected interval rebleeding.It should be noted that a follow-up ct scan was done on (b)(6) 2021 and the interval rebleeding was resolved.Increase in size of right basal ganglia hematoma was adjudicated to be an adverse event related to the artemis, the index procedure, the index intracerebral hemorrhage (ich) and to the comorbidity by the clinical events committee (cec).On 02-nov-2021, we received an update indicating that the clinical events committee (cec) determined the intracranial hemorrhage to be an adverse event related to the artemis, the index procedure and the index intracerebral hemorrhage (ich).

• 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: 12110517
• Report Number: 3005168196-2021-01464
• Device Sequence Number: 3705103
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 12/08/2021
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2022
• Device Model Number: AP28-A
• Device Catalogue Number: AP28
• Device Lot Number: C24776
• 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: 06/04/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• 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: Other
• Patient Age: 44 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005