MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-21 for WINGSPAN STENT SYSTEM 4.0MM X 20MM - CE M003WE0400200 manufactured by Stryker Neurovascular Cork.
[176664306]
The device is not available to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[176664307]
It was reported that when the stent (subject device) was delivered to the lesion during the procedure, the inner shaft broke during deployment. The physician proceeded to withdraw the stent and replace it with a new stent. The procedure continued and completed the procedure successfully without clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00011 |
| MDR Report Key | 9613221 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-21 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-05-20 |
| Date Added to Maude | 2020-01-21 |
| 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 | WINGSPAN STENT SYSTEM 4.0MM X 20MM - CE |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-01-21 |
| Catalog Number | M003WE0400200 |
| Lot Number | 21444722 |
| 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 | 2020-01-21 |