MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-02-20 for NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE M003EZAS30150 manufactured by Stryker Neurovascular Cork.
[180618805]
Subject device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[180618806]
It was reported that a stent (subject device) was successfully implanted for an aneurysm located at the right middle cerebral artery (mca), at the main branch (trifurcation). Modified raymond scale post procedure was class 1. Approximately 2 year-post- procedure, the patient experienced an ischemic stroke; there was slow flow into the parietal branch covered by the subject stent observed by dsa. The patient has been experiencing left arm sensitive deficit for one year. According to the physician, the adverse event of ischemic stroke is most likely related to the implanted subject stent and not the vessel. Patient outcome is ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00046 |
| MDR Report Key | 9736259 |
| Report Source | STUDY |
| Date Received | 2020-02-20 |
| Date of Report | 2020-02-20 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-02-20 |
| 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 3.0MM X 15MM NO TIP - CE |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-02-20 |
| Catalog Number | M003EZAS30150 |
| Lot Number | 19248216 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-20 |