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 Intracranial Hemorrhage (1891)

Event Date 05/19/2021

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.Potential adverse events in the labeling with artemis neuro evacuation device include, but are not limited to, intraventricular hemorrhage, hematoma, headaches, re-bleeding, hydrocephalus, thromboembolic events, craniotomy, unintended removal of tissue leading to neurological and/or sensory deficit 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 micro neurosurgery procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis) and there were no reported complications during the procedure.On (b)(6) 2021, the computed tomography (ct) scan performed post mis procedure revealed a tiny amount of blood within the dependent portions of the lateral ventricles.There was rightward displacement and compression of the lateral and 3rd ventricles.It should be noted that no action was taken to treat the intraventricular hemorrhage (ivh).However, the event was considered resolved on (b)(6) 2021 and the patient was discharged to skilled nursing facility on (b)(6) 2021 for medical management.The clinical events committee (cec) adjudicated the intraventricular hemorrhage (ivh) as an adverse event related to the artemis, the index intracerebral hemorrhage (ich) 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: 12840804
• MDR Text Key: 281160245
• Report Number: 3005168196-2021-02617
• 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: 01/01/2005,11/18/2021

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 Model Number: AP28-A
• Device Catalogue Number: AP28
• Device Lot Number: C24846
• 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: 10/27/2021
• Initial Date FDA Received: 11/18/2021
• 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
• Patient Age: 73 YR
• Patient Sex: Male