MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-06 for ARTEMIS NEURO EVACUATION DEVICE AP28 manufactured by Penumbra, Inc..
[119488214]
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.
Patient Sequence No: 1, Text Type: N, H10
[119488215]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2018-01755 |
| MDR Report Key | 7853526 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-07-11 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2017-08-14 |
| Date Added to Maude | 2018-09-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MISS VERONICA FARRIS |
| Manufacturer Street | ONE PENUMBRA PLACE |
| Manufacturer City | ALAMEDA CA 94502 |
| Manufacturer Country | US |
| Manufacturer Postal | 94502 |
| Manufacturer Phone | 5107483200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTEMIS NEURO EVACUATION DEVICE |
| Generic Name | GWG |
| Product Code | GWG |
| Date Received | 2018-09-06 |
| Catalog Number | AP28 |
| Lot Number | S10002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENUMBRA, INC. |
| Manufacturer Address | ONE PENUMBRA PLACE ALAMEDA CA 94502 US 94502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-06 |