MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-12 for WINGSPAN STENT SYSTEM 3.0MM X 15MM - CE M003WE0300150 manufactured by Stryker Neurovascular Cork.
[179336604]
The subject device is not available to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[179336605]
It was reported that the subject stent was unable to deploy at the lesion after multiple attempts and due to friction, the stent delivery pole got fractured around the middle cerebral artery inside the patient's anatomy during the procedure. The physician then withdrew the subject stent with the 3m guidewire and replaced it with a new stent to complete the procedure successfully. There were no reported clinical consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00038 |
| MDR Report Key | 9703473 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2019-11-11 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-02-12 |
| 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 3.0MM X 15MM - CE |
| Generic Name | STENT, INTRACRANIAL NEUROVASCULAR |
| Product Code | NJE |
| Date Received | 2020-02-12 |
| Catalog Number | M003WE0300150 |
| Lot Number | 21191325 |
| 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 | 2020-02-12 |