FDA Adverse Event
Injury
Summary report: N
SPIDERFX EMBOLIC PROTECTION DEVICE
MDR report key: 1241245
·
Received November 7, 2008
Report
- Report Number
- 2183870-2008-00170
- Event Type
- Injury
- Date Received
- November 7, 2008
- Date of Event
- October 7, 2008
- Report Date
- October 28, 2008
- Manufacturer
- EV3 INC.
- Product Code
- NTE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PLEASE REFERENCE MDR 2183870-2008-00171 FOR PROTEGE RX USED IN THIS PROCEDURE.
Description of Event or Problem · 1
PATIENT ENROLLED INTO THE TRIAL. MINOR ISCHEMIC STROKE-PATIENT EXPERIENCED EXPRESSIVE APHASIA ON THE DAY FOLLOWING THE STENT PROCEDURE. RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDERFX EMBOLIC PROTECTION DEVICE | NTE | EV3 INC. | SPD2-US-060-320 | 6635605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |