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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.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) 2019, the patient underwent a microneurosurgery procedure primarily in the lobar system using an artemis neuro evacuation device (artemis).There was no reported complication during the procedure.However, a follow up computed tomography (ct) scan was performed after the procedure on (b)(6) 2019 and indicated a postsurgical brainstem bleed with blood products tracking interiorly into the posterior limb of the right internal capsule, cerebral peduncle, as well as the dorsal midbrain and pons.It was reported that there was a stable 6 mm midline shift and interval decrease in the size of the left lateral ventricle.Subsequently, continuous electroencephalography (ceeg) monitoring was performed for a 24-hour period and it was noted that the patient's clinical exam results decreased.The patient did not follow commands, flexed in bilateral lower extremities (b/l le), extended in bilateral upper extremities (b/l ue), and had a weak cough.The brainstem bleed was considered to be a serious adverse event with a probable relationship to both the artemis and to the index procedure.On (b)(6) 2019, the patient suffered a right occipital lobe stroke.Subsequently, another ct scan was performed which indicated minimally invasive hematoma drainage and unchanged appearance of intraventricular, parenchymal, and subdural blood products.Additionally, new hypodensities in the right occipital and parietal lobes with loss of gray-white matter differentiation were noted, which may represent new ischemia and infarction.The right occipital lobe stroke was considered to be a serious adverse event with a probable relationship to both the artemis and to the index procedure.On (b)(6) 2019, the patient was moved to full time comfort care.The patient passed away due to the initial intracerebral hemorrhage on (b)(6) 2019.The patient's death was adjudicated to be a serious adverse event with a possible relationship to both the artemis and the index procedure.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8880394
• Report Number: 3005168196-2019-01548
• Device Sequence Number: 2206042
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 07/10/2019
• 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 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: 07/10/2019
• Initial Report FDA Received Date: 08/09/2019
• 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; Required Intervention
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005