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	Seizures (2063); Tissue Damage (2104); Brain Injury (2219)
Date of Event	03/21/2020
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, seizures, decreased consciousness, re-bleeding, thromboembolic events, 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) 2020, the patient underwent a thrombectomy procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis).There were no reported procedural complications.On (b)(6) 2020, the patient was discharged to a rehabilitation facility.On (b)(6) 2020, the patient was noticed to begin experiencing seizure-like activity.The patient¿s eyes would roll back, their body would shake, and the patient would take several deep breaths.These symptoms would last for a few seconds before resolving and would reoccur every thirty minutes.On (b)(6) 2020, while undergoing physical therapy, these symptoms were noticed to reoccur every two minutes.The patient would clamp their eyes shut.Upon opening their eyes, the patient¿s eyes would roll back.It was unknown if the patient was experiencing seizures or if the patient was having pulmonary embolism.On (b)(6) 2020, the patient was sent to the emergency room regarding these symptoms for further evaluation and treatment; subsequently, the patient was hospitalized.Computed tomography (ct) scans for the brain and chest, an electroencephalogram (eeg) and ventilation-perfusion scan of the lung were performed.On a ct scan, it showed the patient had new encephalomalacia in the left insular cortex.The patient was then treated with medication and underwent another medical procedure for the seizure-like activity.No action was taken for the encephalomalacia.As of (b)(6) 2020, the seizure-like activity and encephalomalacia are ongoing.The seizure-like activity and encephalomalacia were adjudicated to be serious adverse events with a definite relationship to the artemis and the index procedure.
Event or Problem Description
On (b)(6) 2020, the patient underwent a thrombectomy procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis).There were no reported procedural complications.On (b)(6) 2020, the patient was discharged to a rehabilitation facility.On (b)(6) 2020, the patient was noticed to begin experiencing seizure-like activity.The patient¿s eyes would roll back, their body would shake, and the patient would take several deep breaths.These symptoms would last for a few seconds before resolving and would reoccur every thirty minutes.On (b)(6) 2020, while undergoing physical therapy, these symptoms were noticed to reoccur every two minutes.The patient would clamp their eyes shut.Upon opening their eyes, the patient¿s eyes would roll back.It was unknown if the patient was experiencing seizures or if the patient was having pulmonary embolism.On (b)(6) 2020, the patient was sent to the emergency room regarding these symptoms for further evaluation and treatment; subsequently, the patient was hospitalized.Computed tomography (ct) scans for the brain and chest, an electroencephalogram (eeg) and ventilation-perfusion scan of the lung were performed.On a ct scan, it showed the patient had new encephalomalacia in the left insular cortex.The patient was then treated with medication and underwent another medical procedure for the seizure-like activity.No action was taken for the encephalomalacia.As of (b)(6) 2020, the seizure-like activity and encephalomalacia are ongoing.The seizure-like activity and encephalomalacia were adjudicated to be serious adverse events with a relationship to the artemis and the index procedure.
Additional Manufacturer Narrative
Please note that the following section has been updated based on additional information provided by the penumbra clinical team on (b)(6) 2020: section b.Box 5.Describe event or problem h3 other text: placeholder.
Additional Manufacturer Narrative
Please note that the following section has been updated based on additional information provided by the penumbra clinical team on 16-dec-2020: section b.Box 5.Describe event or problem.
Event or Problem Description
On (b)(6) 2020, the patient underwent a thrombectomy procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis).There were no reported procedural complications.On (b)(6) 2020, the patient was discharged to a rehabilitation facility.On (b)(6) 2020, the patient was noticed to begin experiencing seizure-like activity.The patient¿s eyes would roll back, their body would shake, and the patient would take several deep breaths.These symptoms would last for a few seconds before resolving and would reoccur every thirty minutes.On (b)(6) 2020, while undergoing physical therapy, these symptoms were noticed to reoccur every two minutes.The patient would clamp their eyes shut.Upon opening their eyes, the patient¿s eyes would roll back.It was unknown if the patient was experiencing seizures or if the patient was having pulmonary embolism.On (b)(6) 2020, the patient was sent to the emergency room regarding these symptoms for further evaluation and treatment; subsequently, the patient was hospitalized.Computed tomography (ct) scans for the brain and chest, an electroencephalogram (eeg) and ventilation-perfusion scan of the lung were performed.On a ct scan, it showed the patient had new encephalomalacia in the left insular cortex.The patient was then treated with medication and underwent another medical procedure for the seizure-like activity.No action was taken for the encephalomalacia.As of (b)(6) 2020, the seizure-like activity and encephalomalacia are ongoing.On (b)(6) 2020, the encephalomalacia was determined to be part of the evolution of the ich and not an adverse event.The seizure-like activity was adjudicated to be a serious adverse event with a relationship to 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 10040873
• Report Number: 3005168196-2020-00638
• Device Sequence Number: 2813343
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/14/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 09/14/2020; 12/16/2020; 12/16/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 11/09/2020; 01/13/2021; 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005