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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hydrocephalus (3272)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
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.Therefore, it was determined that the reported adverse event was anticipated complications.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) 2020, we received an update that the re-hemorrhage was an adverse event which the site determined to be unrelated to the artemis neuro evacuation device (artemis).On (b)(6) 2021, we were made aware that the patient suffered hydrocephalus on (b)(6) 2020.The computed tomography scan (ct) revealed worsening extra-axial collection and left cerebral convexity, as well as worsening midline shift and ventricular dilatation.It was also noted that there was probably transependymal flow cerebrospinal fluid (csf).The cec adjudicated the hydrocephalus to be related to artemis, to the index procedure, to the patient's comorbidity and to the intracranial hemorrhage (ich).
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the clinical events committee on (b)(6) 2021: 1.Section b.Box 5.Describe event or problem.2.Section h.Patient code 2 h3 other text : placeholder.
Event or Problem Description
On (b)(6) 2020, the patient underwent a thrombectomy procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis).There were no procedural complications reported.On (b)(6) 2020, the patient displayed a slight increased prominence of the lateral ventricles and an intraventricular re-hemorrhage in the occipital horns was noted.However, the event was considered resolved as of (b)(6) 2020.On (b)(6) 2020 we were made aware that the cec adjudicated the re-hemorrhage to be a serious adverse event related to artemis, to the procedure, to the patient¿s comorbidity, and to the index intracranial hemorrhage (ich).On (b)(6) 2021, we were made aware that the patient suffered hydrocephalus on (b)(6) 2020.The computed tomography scan (ct) revealed worsening extra-axial collection and left cerebral convexity, as well as worsening midline shift and ventricular dilatation.It was also noted that there was probably transependymal flow cerebrospinal fluid (csf).A medical procedure was performed to treat the hydrocephalus and the event was considered resolved as of (b)(6) 2020.The cec adjudicated the hydrocephalus to be a serious adverse event related to artemis, to the index procedure, to the patient's comorbidity, and to the index intracranial hemorrhage (ich).On (b)(6) 2021, we were made aware that the patient¿s ct scan on (b)(6) 2020 revealed new hypodense subdural hygroma.A medical procedure was performed to treat the subdural hygroma and the event was considered resolved as of (b)(6) 2020.The cec adjudicated the subdural hygroma to be a serious adverse event related to artemis, to the index procedure, and to the index intracranial hemorrhage (ich).

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11412685
• Report Number: 3005168196-2021-00395
• Device Sequence Number: 4369785
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K171332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005