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

Model Number AP28-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seizures (2063); Tissue Damage (2104); Brain Injury (2219)

Event Date 03/21/2020

Event Type  Injury  

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 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 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 191393432
• Report Number: 3005168196-2020-00638
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K171332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female