FDA Adverse Event
Malfunction
Summary report: N
WINGSPAN STENT SYSTEM
MDR report key: 1073719
·
Received July 1, 2008
Report
- Report Number
- 2939204-2008-00267
- Event Type
- Malfunction
- Date Received
- July 1, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 4, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORP.
- Product Code
- NJE
- PMA / PMN Number
- H050001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
STENT SYSTEM PREMATURELY DEPLOYED. PT CONDITION IS REPORTED TO BE GOOD. (NO FURTHER INFO HAS BEEN DISCLOSED AT THIS TIME.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WINGSPAN STENT SYSTEM | (NJE) NEUROVASCULAR WINGSPAN STENT | NJE | BOSTON SCIENTIFIC CORP. | WS035015 | 11219318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |