MAUDE Adverse Event Report: PENUMBRA, INC. ARTEMIS NEURO EVACUATION DEVICE; GWG

Catalog Number	AP28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hemorrhage, Subarachnoid (1893); Respiratory Distress (2045)
Date of Event	06/19/2018
Type of Reportable Event	Death
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 evacuation device include, but are not limited to, decreased consciousness, intraventricular hemorrhage at the site, including death.Therefore, it was determined that the reported adverse events were 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
The patient underwent a thrombectomy procedure to treat a right frontal intracerebral hemorrhage (ich), using an artemis neuro evacuation device (artemis) on (b)(6) 2018.On (b)(6) 2018, the patient developed delirium.The physician; therefore, administered medication for agitation and fluctuating levels of alertness.Additional information was received on 28-aug-2018 indicating that the principle investigator (pi) updated his opinion on this event and reported it to be not related to artemis.Approximately eight months later, an update was received on (b)(6) 2019 indicating that on (b)(6) 2018, the patient experienced subdural hygroma.The subdural hygroma was adjudicated to be an adverse event related to the artemis, index intracerebral hemorrhage (ich), the index procedure and unrelated to the comorbidity.An update received on 05-may-2019 indicated that on (b)(6) 2018, the patient experienced increased respiratory distress and became unresponsive.Therefore, the patient was sent to the emergency room (er) and was intubated.After discussion with the family, it was felt that the patient would not want to continue aggressive medical care, given his protracted recovery to date, and the decision was made to transition to comfort care measures.The patient was extubated and transferred to hospice care and expired on (b)(6) 2018.The clinical events committee (cec) adjudicated the respiratory failure as a serious adverse event related to the artemis, the index intracerebral hemorrhage (ich), the index procedure and the comorbidity.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8666312
• Report Number: 3005168196-2019-01017
• Device Sequence Number: 2257711
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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
• Report Date (Section B): 05/05/2019
• 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: 10/29/2020
• Device Catalogue Number: AP28
• Device Lot Number: S10003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/04/2019
• 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: Death
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005