FDA Adverse Event
Injury
Summary report: N
SPIDERFX EMBOLIC PROTECTION DEVICE
MDR report key: 1222080
·
Received November 6, 2008
Report
- Report Number
- 2183870-2008-00165
- Event Type
- Injury
- Date Received
- November 6, 2008
- Date of Event
- March 19, 2008
- Report Date
- October 16, 2008
- Manufacturer
- EV3 INC.
- Product Code
- NTE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PLEASE REFERENCE MDR 2183870-2008-00164 FOR PROTÉGÉ RX USED IN THIS PROCEDURE.
Description of Event or Problem · 1
PATIENT ENROLLED INTO THE CREATE PAS TRIAL. TIA REPORTED-NOT DEVICE RELATED; LISTED AS RELATED TO THE PROCEDURE. PATIENT WAS FOUND TO HAVE RIGHT SIDE WEAKNESS. NO ACTION TAKEN AND RECOVERED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDERFX EMBOLIC PROTECTION DEVICE | NTE | EV3 INC. | SPD2-US-070-190 | 2542262 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |