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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/19/2021
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, 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.Therefore, it was determined that the reported adverse event was 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) 2021, the patient underwent a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using artemis neuro evacuation device (artemis).There were no procedural complications reported.On (b)(6) 2021, the computed tomography (ct) scan revealed a worsening of the intraventricular hemorrhage (ivh).It should be noted that no action was taken to treat the worsening of the ivh.On (b)(6) 2021, the patient expired due to cardiopulmonary arrest.The patient''s death was reported to be unrelated to the artemis.The worsening of the ivh was reported to be a serious adverse event with a possible relationship to the artemis and index procedure.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the clinical events committee (cec) on 29-jan-2022: 1.Section b.Box 5.Describe event or problem.2.Section h.Box 6.Patient code 2.Section h.Box 6.Patient code 2: 4581 - appropriate code not available to describe "acute infarction in the left hemisphere".
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).There were no procedural complications reported.On (b)(6) 2021, the patient¿s ct scan revealed a worsening of the intraventricular hemorrhage (ivh).It should be noted that no action was taken to treat the worsening of the ivh.On (b)(6) 2021, the patient expired due to cardiopulmonary arrest.The patient''s death was reported to be unrelated to the artemis.On (b)(6) 2022, additional information was received indicating that the patient¿s computed tomography (ct) scan, following the procedure on (b)(6) 2021, revealed trace right hemispheric subarachnoid hemorrhage (sah) in the basilar cisterns extending into the proximal cervical canal.It should be noted that no action was taken to treat the sah.On (b)(6) 2022, additional information was also received indicating that the patient¿s ct scan on (b)(6) 2021 showed new acute infarction in the left hemisphere in the distribution of the middle cerebral artery (mca).It should be noted that no action was taken to treat the acute infarction.The worsening of the ivh was reported to be a serious adverse event with a possible relationship to the artemis and index procedure.The event was considered unresolved at the time of study exit.On (b)(6) 2022, additional information indicated that the clinical events committee (cec) adjudicated the worsening of the ivh to be a serious adverse event related to the artemis, the index ich and index procedure and unrelated to the comorbidity.The cec adjudicated the sah to be a serious adverse event related to the artemis and index procedure and unrelated to the index ich and comorbidity.The cec also adjudicated the acute left fronto-parietal infarction to be a serious adverse event related to the artemis, the index ich, the index procedure, and 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: 11901154
• Report Number: 3005168196-2021-01182
• Device Sequence Number: 17244091
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K171332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2021
• Device Model Number: AP28-A
• Device Catalogue Number: AP28
• Device Lot Number: S10009
• 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: 04/30/2021
• Supplement Date Received by Manufacturer: 01/29/2022
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 02/16/2022
• 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: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005