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 2019-05-31 for ARTEMIS NEURO EVACUATION DEVICE AP28 manufactured by Penumbra, Inc..
[146799870]
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.
Patient Sequence No: 1, Text Type: N, H10
[146799871]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2019-01078 |
| MDR Report Key | 8660813 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-01-30 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-06-06 |
| Device Manufacturer Date | 2018-01-23 |
| Date Added to Maude | 2019-05-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. 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 | 2019-05-31 |
| Catalog Number | AP28 |
| Lot Number | S10005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-05-31 |