FDA Adverse Event
Other
Summary report: N
SPIDERFX EMBOLIC PROTECTION DEVICE
MDR report key: 1202842
·
Received October 14, 2008
Report
- Report Number
- 2183870-2008-00141
- Event Type
- Other
- Date Received
- October 14, 2008
- Date of Event
- September 10, 2008
- Report Date
- October 2, 2008
- Manufacturer
- EV3 INC.
- Product Code
- NTE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PLEASE REFERENCE MDR 2183870-2008-00142 FOR THE PROTEGE RX USED IN THIS PROCEDURE.
Description of Event or Problem · 1
PATIENT ENROLLED INTO THE (B) (6), EMBOLISM OF AIR, PLAQUE, THROMBUS, OR DEBRIS REPORTED RESULTING IN RIGHT EYE RETINAL ARTERY OCCLUSION. PATIENT NOTED BLURRED VISION 8.5 HOURS AFTER CAROTID ARTERY STENT PLACEMENT (RIGHT ICA). THE PATIENT WAS EVALUATED BY A NEUROLOGIST AND OPHTHALMOLOGIST. ON (B) (6), 2008, PATIENT REPORTED NO CHANGE IN VISION SINCE LAST VISIT; CONTINUES TO HAVE BLURRING OF CENTRAL RIGHT EYE VISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDERFX EMBOLIC PROTECTION DEVICE | NTE | EV3 INC. | SPD2-US-060-320 | 5500107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |