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

Catalog Number AP28

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage, Subdural (1894)

Event Date 01/30/2019

Event Type  Injury  

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, re-bleeding, intraventricular hemorrhage, thromboembolic events, 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 Description

On (b)(6) 2019, the patient underwent a minimally invasive surgery (mis) using an artemis neuro evacuation device (artemis).It was reported that the ct scan showed the patient had a re-bleeding intracerebral hemorrhage (ich).Therefore, the patient underwent another mis with an artemis.The patient was discharged to a rehabilitation center on (b)(6) 2019.This re-bleeding ich was adjudicated to be an adverse event related to the artemis, the index ich, the index procedure, and to the comorbidity with the atrial fibrillation which required treatment with eliquis.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 06/06/2019.

Event Description

On (b)(6) 2019, the patient underwent a minimally invasive surgery (mis) using an artemis neuro evacuation device (artemis).It was reported that the ct scan showed the patient had a re-bleeding intracerebral hemorrhage (ich).Therefore, the patient underwent another mis with an artemis.The patient was discharged to a rehabilitation center on (b)(6) 2019.This re-bleeding ich was adjudicated to be a serious adverse event related to the artemis, the index ich, the index procedure, and to the comorbidity with the atrial fibrillation which required treatment with eliquis.

• Brand Name: ARTEMIS NEURO EVACUATION DEVICE
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8660813
• MDR Text Key: 146799870
• Report Number: 3005168196-2019-01078
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00814548017877
• UDI-Public: 00814548017877
• Combination Product (y/n): Y
• PMA/PMN Number: K171332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• 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 Catalogue Number: AP28
• Device Lot Number: S10005
• Was Device Available for Evaluation?: No
• 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: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR