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 2018-12-05 for ARTEMIS NEURO EVACUATION DEVICE AP28 manufactured by Penumbra, Inc..
[129521271]
The product was not returned for evaluation. Without the return of the device, the root cause of the problem cannot be determined. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. Edema is a known and anticipated complication with these types of procedures and are noted in the device labeling. Therefore, it was determined that these reported adverse events were anticipated procedural complications.
Patient Sequence No: 1, Text Type: N, H10
[129521272]
On (b)(6) 2018, the patient underwent a micro-neurosurgery procedure using an artemis neuro evacuation device (artemis). There was no reported complication during the procedure. However, a follow up computed tomography (ct) performed on (b)(6) 2018 demonstrated evolving edema. The patient then underwent a craniotomy to relieve malignant cerebral edema. The evolving edema was reported to be a serious adverse event with a probable relationship to the artemis and the index procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005168196-2018-02369 |
| MDR Report Key | 8135969 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-05 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-10-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2018-11-06 |
| Device Manufacturer Date | 2017-08-17 |
| Date Added to Maude | 2018-12-05 |
| 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 | 2018-12-05 |
| 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 | 2018-12-05 |