MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-04 for NEUROFORM ATLAS STENT SYSTEM 3.0 X 21MM WITHOUT TIP M003EZAS30210 manufactured by Stryker Neurovascular Cork.
[177842785]
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications. The reported event is covered in the device directions for use (dfu). As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event. During the analysis of the returned device, it was revealed that the stent was deformed. The functioning test cannot be performed due to the condition of the returned device. However, based on the returned device, it can be presumed that there was friction felt advancing the stent and this caused the stent to prematurely deploy. Therefore, a probable cause of procedural factors will be assigned to the reported and analyzed event, as these defects appear to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Patient Sequence No: 1, Text Type: N, H10
[177842786]
During the analysis of the returned device, it was revealed that the stent was prematurely deployed during use. No clinical consequences reported to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00030 |
| MDR Report Key | 9667167 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-11-06 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-04-04 |
| Date Added to Maude | 2020-02-04 |
| 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 21MM WITHOUT TIP |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-02-04 |
| Returned To Mfg | 2019-11-21 |
| Catalog Number | M003EZAS30210 |
| Lot Number | 21353932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-04 |