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 Hematoma (1884)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Potential adverse events in the labeling with the artemis neuro evacuation device include, but are not limited to, hematoma expansion, intraventricular hemorrhage, hydrocephalous, including death.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) 2021, the patient underwent a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using artemis neuro evacuation device (artemis).On (b)(6) 2021, the computed tomography (ct) scan revealed an interval increase in size of right basal ganglia hematoma and increased associated mass effect compared to the (b)(6) 2021 exam, with suspected interval rebleeding.It should be noted that a follow-up ct scan was done on (b)(6) 2021 and the interval rebleeding was resolved.Increase in size of right basal ganglia hematoma was reported to be an adverse event with a possible relationship to the artemis and index procedure.

Event Description

On (b)(6) 2021, the patient underwent a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using artemis neuro evacuation device (artemis).On 18-may-2021, the computed tomography (ct) scan revealed an interval increase in size of right basal ganglia hematoma and increased associated mass effect compared to the (b)(6) 2021 exam, with suspected interval rebleeding.It should be noted that a follow-up ct scan was done on (b)(6) 2021 and the interval rebleeding was resolved.Increase in size of right basal ganglia hematoma was adjudicated to be an adverse event related to the artemis, the index procedure, the index intracerebral hemorrhage (ich) and to the comorbidity by the clinical events committee (cec).On 02-nov-2021, we received an update indicating that the clinical events committee (cec) determined the intracranial hemorrhage to be an adverse event related to the artemis, the index procedure and the index intracerebral hemorrhage (ich).

• 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: 12110517
• MDR Text Key: 260083108
• Report Number: 3005168196-2021-01464
• 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
• Report Date: 01/01/2005,12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2022
• Device Model Number: AP28-A
• Device Catalogue Number: AP28
• Device Lot Number: C24776
• 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: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2018
• 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: 44 YR
• Patient Sex: Female