FDA Adverse Event
Injury
Summary report: N
PROTEGE RX CAROTID
MDR report key: 1241248
·
Received November 7, 2008
Report
- Report Number
- 2183870-2008-00169
- Event Type
- Injury
- Date Received
- November 7, 2008
- Date of Event
- September 23, 2008
- Report Date
- October 16, 2008
- Manufacturer
- EV3 INC.
- Product Code
- NIM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PLEASE REFERENCE MDR 2183870-2008-00160 FOR SPIDERFX USED IN THIS PROCEDURE.
Description of Event or Problem · 1
PATIENT ENROLLED INTO THE TRIAL. TIA REPORTED, NOT DEVICE RELATED; NOTED AS PROCEDURE RELATED. PATIENT EXPERIENCED RIGHT ARM WEAKNESS POST CAROTID STENT BALLOON DILATION. ARM STRENGTH CONTINUED TO IMPROVE. FILTER REMOVED SHOWING DEBRIS IN THE BASKET. PATIENT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEGE RX CAROTID | NIM | NIM | EV3 INC. | SECX-10-7-40-135 | 5416946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |