FDA Adverse Event
Injury
Summary report: N
PROTÉGÉ ®RX SELF EXPANDING NITINOL STENT
MDR report key: 2022360
·
Received March 17, 2011
Report
- Report Number
- 2183870-2011-00041
- Event Type
- Injury
- Date Received
- March 17, 2011
- Date of Event
- January 27, 2011
- Report Date
- February 17, 2011
- Manufacturer
- EV3 INC.
- Product Code
- NIM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.
Description of Event or Problem · 1
THIS PROCEDURE IS PART OF THE CREATE PAS TRIAL A MINOR ISCHEMIC STROKE WAS REPORTED. INITIALLY THE PATIENT HAD NO DEFICITS AFTER POST-STENT DILATATION AND EMBOLIC PROTECTION DEVICE (EPD) REMOVAL. HOWEVER, LATER THE SAME DAY, THE PATIENT COMPLAINED OF RIGHT HAND/ARM WEAKNESS AND DECREASED SENSATION. AGGRASTAT WAS STARTED AND FURTHER DILATATION WAS PERFORMED. THE PATIENT IS NOT YET RECOVERED. PLEASE REFERENCE MDR 2183870-2011-00042 FOR THE SPIDERFX USED IN THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTÉGÉ ®RX SELF EXPANDING NITINOL STENT | STENT, CAROTID | NIM | EV3 INC. | SECX-10-7-40-135 | 9319284 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Other | SPIDERFX |