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	Hemorrhage, Intraventricular (1892)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 event was anticipated complication.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) 2020, the patient underwent a thrombectomy procedure to evacuate a right primary deep intracerebral hemorrhage using an artemis neuro evacuation device (artemis).There was no reported complication or device malfunction during the procedure.However, a follow up computed tomography (ct) scan performed 24 hours post-procedure indicated the presence of trace intraventricular blood.On (b)(6) 2020, the patient was reportedly improving and was discharged to the general medical/surgical ward.The intraventricular blood was reported to be a non-serious adverse event with a probable relationship to the artemis and index procedure.
Event or Problem Description
On (b)(6) 2020, the patient underwent a thrombectomy procedure to evacuate a right primarily deep intracerebral hemorrhage using an artemis neuro evacuation device (artemis).There was no reported complication or device malfunction during the procedure.However, a follow up computed tomography (ct) scan performed 24 hours post-procedure indicated the presence of trace intraventricular blood.On (b)(6) 2020, the patient was reportedly improving and was discharged to the general medical/surgical ward.The intraventricular blood was reported to be a non-serious adverse event with a probable relationship to the artemis and index procedure.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2020-00396.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9851259
• Report Number: 3005168196-2020-00396
• Device Sequence Number: 19691246
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020
• 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: 08/13/2020
• Device Model Number: AP28-A
• Device Catalogue Number: AP28
• Device Lot Number: S10002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005