MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-01-22 for NEUROFORM ATLAS STENT SYSTEM 3.0 X 24MM WITHOUT TIP M003EZAS30240 manufactured by Stryker Neurovascular Cork.
[176100697]
Subject device remains implanted.
Patient Sequence No: 1, Text Type: N, H10
[176100698]
It was reported that core lab imaging (angiography) 12-16 month-post stent-assisted coil embolization procedure with the subject stent for an aneurysm located at the right middle cerebral artery (mca), core lab imaging revealed 100% parent artery occlusion and thromboembolism in the aneurysm neck and distal branch. The facility did not report any adverse consequences to the patient at the follow-up visits during the same times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00015 |
| MDR Report Key | 9618585 |
| Report Source | STUDY |
| Date Received | 2020-01-22 |
| Date of Report | 2020-02-11 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2016-07-19 |
| Date Added to Maude | 2020-01-22 |
| 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 STENT SYSTEM 3.0 X 24MM WITHOUT TIP |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-01-22 |
| Catalog Number | M003EZAS30240 |
| Lot Number | 19192953 |
| 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 | 2020-01-22 |