FDA Adverse Event
Injury
Summary report: N
WINGSPAM STENT SYSTEM
MDR report key: 696752
·
Received April 5, 2006
Report
- Report Number
- 6000078-2006-00093
- Event Type
- Injury
- Date Received
- April 5, 2006
- Date of Event
- January 20, 2006
- Report Date
- April 3, 2006
- Manufacturer
- BOSTON SCIENTIFIC CORP, NEUROVASCULAR
- Product Code
- NIO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC CORP BECAME AWARE THAT THE PT UNDERWENT SUCCESSFUL TREATMENT OF A VERTEBRAL ARTERY ANEURYSM 2006. A FEW DAYS LATER THE PT DEVEOPED HEMORHAGE (STROKE) OF THE LEFT FRONTAL LOBE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WINGSPAM STENT SYSTEM | INTRAVASCULAR STENT | NIO | BOSTON SCIENTIFIC CORP, NEUROVASCULAR | * | 7987652 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Death |