MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-01-17 for UNKNOWN_NEUROVASCULAR_PRODUCT UNK_NEU manufactured by Stryker Neurovascular Cork.
[176099638]
The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned. Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release. 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. Based on the event description, the stent moved unexpectedly and lead to the need to re-canalization and re-embolization of the aneurysm. The as reported events will be assigned procedural factors as well as the as reported patient medical or surgical intervention required as this was an offset of the deployment issues in the initial procedure, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited. Subject device is not available.
Patient Sequence No: 1, Text Type: N, H10
[176099639]
It was reported that during the procedure, the subject stent was deployed at internal carotid un-ruptured aneurysm. The distal part of the subject stent moved distally and deployed from the target vessel and the proximal part of the subject stent was dropped into the aneurysm. The physician then deployed a coil and completed the procedure. About 13 months after completing the procedure, re-canalization of the aneurysm was confirmed and re- embolization was done using another stent and 10 coils. The physician successfully completed the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00008 |
| MDR Report Key | 9604415 |
| Report Source | LITERATURE |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2017-04-01 |
| Date Mfgr Received | 2019-12-26 |
| Date Added to Maude | 2020-01-17 |
| 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 Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_NEUROVASCULAR_PRODUCT |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-01-17 |
| Catalog Number | UNK_NEU |
| 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 NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-17 |