FDA Adverse Event
Injury
Summary report: N
SPIDERFX¿ EMBOLIC PROTECTION DEVICE
MDR report key: 2042865
·
Received April 7, 2011
Report
- Report Number
- 2183870-2011-00058
- Event Type
- Injury
- Date Received
- April 7, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 9, 2011
- 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
A REVIEW OF THE MANUFACTURING RECORDS FOR DEVICE LOT DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.
Description of Event or Problem · 1
THIS PROCEDURE WAS PART OF (B)(6). AFTER A CAROTID STENTING PROCEDURE, A TIA WAS REPORTED POST PROCEDURE. APHASIA, RIGHT HEMINEGLECT, LEFT HEMIPARESIS/HEMIPLEGIA WERE NOTED. THE PHYSICIAN ORDERED AN MRI AND CT SCAN ASSESSMENT DONE. THE PATIENT RECOVERED WITHOUT SEQUELAE. PER THE SITE, IT IS RELATED TO THE SPIDERFX DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDERFX¿ EMBOLIC PROTECTION DEVICE | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE | NTE | EV3 INC. | SPD2-US-050-320 | 9405310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other | PROTEGE RX |