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 Hematoma (1884); Ischemia Stroke (4418)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

Potential adverse events in the labeling with the artemis neuro evacuation device include, but are not limited to, hematoma expansion, thromboembolic events, re-bleeding, including death.Therefore, it was determined that the reported adverse events were anticipated complications.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.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

On (b)(6) 2019, the patient underwent a medical procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis).After blood evacuation with the artemis, evidence of a new ischemic stroke was determined on computerized tomography (ct) scans.Postoperative seizures were likely due to this stroke.In addition, holocephalic left subdural hematoma was likely the cause of the left hemispheric focal status epilepticus.The events were considered unresolved at the time of the study.On (b)(6) 2019, the patient expired from sepsis in the setting of the ich.The patient's death was unrelated to the artemis.The ischemic stroke was adjudicated to be a serious adverse event related to the artemis, the index ich, the index procedure, and comorbidity.The subdural hematoma was adjudicated to be a non-serious adverse event related to the artemis and 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: 10830888
• MDR Text Key: 215977246
• Report Number: 3005168196-2020-01967
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/16/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: AP28-A
• Device Catalogue Number: AP28
• Device Lot Number: S10006
• 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
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/12/2020
• 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): Other
• Patient Age: 75 YR