FDA Adverse Event
Death
Summary report: N
SPIDERFX EMBOLIC PROTECTION
MDR report key: 3053495
·
Received April 11, 2013
Report
- Report Number
- 2183870-2013-00092
- Event Type
- Death
- Date Received
- April 11, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 15, 2013
- Manufacturer
- EV3 INC.
- Product Code
- NTE
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.
Description of Event or Problem · 1
THE CAS PROCEDURE AS PART OF (B)(4). A MAJOR ISCHEMIC STROKE WAS REPORTED. THE PATIENT HAD A LEFT HEMISPHERIC EVENT DURING THE STENT PROCEDURE ON (B)(6) 2013. THE DURATION OF WHICH WAS GREATER THAN 24 HOURS. THE PATIENT WAS MEDICATED AND IN (B)(6) CARE UNTIL DEATH ON (B)(6) 2013. PER THE SITE, THE DEATH WAS RELATED TO THE PROCEDURE BUT NOT RELATED TO THE DEVICES USED. PLEASE REFERENCE MDR 2183870-2013-00093 FOR THE PROTEGE RX USED IN THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156104 | SPIDERFX EMBOLIC PROTECTION | TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE | NTE | EV3 INC. | SPD2-US-060-320 | 9659900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Death | PROTEGE RX |