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

Model Number	AP28-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Potential adverse events with the artemis neuro evacuation device include hematoma expansion, intraventricular hemorrhage, thromboembolic events, re-bleeding and are included in the labeling.Therefore, it was determined that the reported event was an anticipated complication.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) 2020, the patient underwent a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis).There was no report of device malfunction during the procedure.Following the procedure, the patient started on heparin drip for the treatment of bilateral pulmonary embolism (pe).On (b)(6) 2020 at 04:37, a computed tomography scan (ct scan) showed stable examination.On (b)(6) 2020 at 17:16, a ct scan showed acute 7.6 centimeters intraparenchymal hematoma (iph) in the right basal ganglia with associated vasogenic edema and 10 millimeters leftward shift.The patient was asymptomatic and the re-bleed was an incidental finding on the ct scan.All anticoagulant/antiplatelet treatment was immediately discontinued, and protamine was given.On (b)(6) 2020, a ct scan showed stable iph.As of (b)(6) 2020, the event is still ongoing and the patient is under standard of care treatment plan.The acute iph was reported to be an adverse event with a possible relationship to the artemis and the index procedure.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10102190
• Report Number: 3005168196-2020-00701
• Device Sequence Number: 3572878
• Product Code: HCG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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
• Report Date (Section B): 05/06/2020
• 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: 01/22/2021
• Device Model Number: AP28-A
• Device Catalogue Number: AP28
• Device Lot Number: S10006
• Was Device Available for Evaluation?: No
• 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: 05/06/2020
• Initial Report FDA Received Date: 05/29/2020
• 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: Required Intervention
• Patient Age: 48 YR
• Date Report Sent to FDA: 01/01/2005