FDA Adverse Event
Injury
Summary report: N
PROTEGE RX CAROTID STENTING SYSTEM
MDR report key: 1013112
·
Received March 14, 2008
Report
- Report Number
- 2183870-2008-00034
- Event Type
- Injury
- Date Received
- March 14, 2008
- Date of Event
- November 27, 2007
- Report Date
- March 6, 2008
- Manufacturer
- EV3 INC.
- Product Code
- NIM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REFERENCE MDR 23183870-2008-00035 FOR THE SPIDERFX DEVICE USED IN THIS PROCEDURE.
Description of Event or Problem · 1
PT ENROLLED INTO THE CREATE PAS TRIAL. FOLLOWING STENT PLACEMENT, PT BECAME HYPOTENSIVE AND BRADYCARDIC, AT TIME OF FILTER RETRIEVAL PT DEVELOPED SLURRED SPEECH AND FACIAL DROOPING. AFTER BLOOD PRESSURE AND HEART RATE RETURNED TO NORMAL, SLURRED SPEECH AND FACIAL DROOPING WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEGE RX CAROTID STENTING SYSTEM | NIM | EV3 INC. | SECX-10-7-40-135 | 2426313 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | COOK SHUTTLE SHEATH |