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 Problem Hemorrhage/Bleeding (1888)

Event Date 03/02/2021

Event Type  Death  

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 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
• 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: 12981477
• MDR Text Key: 282089655
• Report Number: 3005168196-2021-02779
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (y/n): N
• 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
• Report Date: 01/01/2005,12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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; Death; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male