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/Bleeding (1888)

Event Date 01/18/2019

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, non conformance, 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, hematoma or hemorrhage at the site, intraventricular hemorrhage, re-bleeding, 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 microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using an artemis neuro evacuation device (artemis).Following the procedure, a computed tomography scan (ct scan) showed a re-hemorrhage of 8 cc in volume into the tissue bed with mass effect, midline shift and, right uncal herniation.The re-hemorrhage was treated with standard medical management.The patient was discharged to a rehabilitation center on (b)(6) 2019 in stable condition and no medications, blood transfusion and medical procedure were required to address the re-hemorrhage into the tissue bed.The re-hemorrhage into the tissue bed was adjudicated to be a serious adverse event related to the artemis, the index ich, the index procedure, and to the comorbidity.

• 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: 9100051
• MDR Text Key: 159421460
• Report Number: 3005168196-2019-01786
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• 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
• 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: 08/22/2019
• 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): Required Intervention
• Patient Age: 67 YR