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 Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/02/2021
Type of Reportable Event	Death
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.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 minimally invasive surgery (mis) procedure in the right parietal and occipital lobes using an artemis neuro evacuation device (artemis).The ultrasound during the procedure showed good evacuation of the hemorrhage, and no procedural complications were reported.The patient remained stable throughout the procedure and remained intubated and sedated while being transferred for a routine post-operative computed tomography (ct) scan of the head.The ct scan revealed a large re-hemorrhage at the same site with extension into the right ventricle.The patient was returned to the operating room (or) and underwent a right craniotomy, evacuation of the re-hemorrhage, and insertion of an external ventricular drain (evd).The patient was then transferred to the neurological critical care unit (nccu).On (b)(6) 2021, the patient demonstrated a worsening in his neurological examination.Immediately following this, the patient had a ct demonstrating new areas of hemorrhage and extensive edema lateral to the primary hemorrhage within the parietal lobe with marked associated midline shift.The patient was transferred to the or for another craniotomy and hemorrhage evacuation.Post-operative ct scan demonstrated further progression of the edema & hemorrhage far lateral to the region of the original hemorrhage and mis procedure.He was returned to the or for extension of his craniectomy with resection of some of the injured brain tissue.Post-op ct showed adequate decompression and reduced midline shift.Magnetic resonance (mr) imaging was completed 3/4 which showed the hemorrhage but no underlying mass.The magnetic resonance angiogram (mra) was reported to be normal.Magnetic resonance venography (mrv) showed patency of the major dural sinuses.Conventional angiography demonstrated an absence of cortical veins over the right parietal and occipital regions.There was no evidence of an arterial vascular lesion or vasculitis to account for this rapidly progressive multifocal hemorrhage and edema.On (b)(6) 2021, the patient could follow some simple commands and was extubated.On (b)(6) 2021, the patient failed to wean and was re-intubated.It was also reported that the patient¿s neurological status was unchanged.Family decided comfort care and the patient was terminally extubated on (b)(6) 2021.The re-hemorrhage and the new cerebral multifocal hemorrhage with edema leading to the patient's expiration were adjudicated to be serious adverse events with a probable relationship to the artemis and a definite relationship to the 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: 12981477
• Report Number: 3005168196-2021-02779
• Device Sequence Number: 20054505
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 12/10/2021
• 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: S10007
• 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: 11/14/2021
• Initial Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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: Hospitalization; Death; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005