MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-02-21 for NEUROFORM ATLAS 4.0MM X 24MM NO TIP - CE M003EZAS40240 manufactured by Stryker Neurovascular Cork.
[180619078]
Subject device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[180619079]
It was reported that the stent (subject device) was successfully implanted for an aneurysm located at the left anterior cerebral, at anterior communicating junction. 12-16-month visit indicated 100% in-stent stenosis and parent vessel stenosis. Approximately 1 year 5 month-post-procedure the patient experienced motor deficit of the right leg (national institutes of health stroke scale (nihss) was 2) related to an ischemic stroke. Magnetic resonance imaging (mir) confirmed cerebral infract next day. The stroke was resolved without sequalae 1 month post adverse event. According to the physician, the ischemic stroke was to the subject stent and to the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00049 |
| MDR Report Key | 9742219 |
| Report Source | STUDY |
| Date Received | 2020-02-21 |
| Date of Report | 2020-03-12 |
| Date of Event | 2018-09-02 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2016-04-26 |
| Date Added to Maude | 2020-02-21 |
| 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 | MR. TARA LOPEZ |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | STRYKER NEUROVASCULAR CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE MODEL FARM ROAD |
| Manufacturer City | CORK NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROFORM ATLAS 4.0MM X 24MM NO TIP - CE |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-02-21 |
| Catalog Number | M003EZAS40240 |
| Lot Number | 19209301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER NEUROVASCULAR CORK |
| Manufacturer Address | IDA INDUSTRIAL ESTATE MODEL FARM ROAD CORK NA IE NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-21 |