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 Seizures (2063)

Event Date 07/11/2018

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.Seizure is a known and anticipated complications with these types of procedures and is noted in the device labeling.Therefore, it was determined that the reported seizure was an anticipated procedural complications.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.

Event Description

The patient underwent a thrombectomy procedure on (b)(6) 2018 to treat an intracerebral hemorrhage in the patient¿s deep basal ganglia using an artemis neuro evacuation device (artemis).During the physical therapy evaluation on (b)(6) 2018, the patient had seizure-like activity on his left upper extremities for 10 seconds; the patient was unresponsive and did not make eye contact.The patient was given medication to treat the seizure.A computed tomography (ct) head scan and an electroencephalogram (eeg) were performed, but there were no abnormalities.This adverse event is considered resolved as of (b)(6) 2018.This seizure was adjudicated to be an adverse event with a possible relationship to the artemis and a possible relationship to 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: 7853526
• MDR Text Key: 119488214
• Report Number: 3005168196-2018-01755
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2020
• Device Catalogue Number: AP28
• Device Lot Number: S10002
• 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: 08/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• 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: 53 YR