FDA Adverse Event
Injury
Summary report: N
SPIDERFX EMBOLIC PROTECTION DEVICE
MDR report key: 1020360
·
Received March 27, 2008
Report
- Report Number
- 2183870-2008-00038
- Event Type
- Injury
- Date Received
- March 27, 2008
- Date of Event
- February 28, 2008
- Report Date
- March 20, 2008
- Manufacturer
- EV3 INC.
- Product Code
- NTE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REFERENCE MDR 2183870-2008-00039 FOR THE PROTEGE RX USED IN THIS PROCEDURE.
Description of Event or Problem · 1
PT ENROLLED INTO THE TRIAL: TIA (NEW NEUROLOGICAL DEFICIT LASTING MORE THAN 10 MINUTES BUT <24 HRS) DURING STENT PLACEMENT, PT BECAME AGITATED, UNRESPONSIVE, MOVING ALL FOUR EXTREMITIES. ANGIO SHOWED PATENCY OF STENT AND NO CUT-OFF INTRACRANIAL VESSELS. PT DID SLOWLY IMPROVE OVER 20 MINUTES. PT IS EXPERIENCING BRADYCARDIA THAT IS REQUIRING MEDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDERFX EMBOLIC PROTECTION DEVICE | NTE | EV3 INC. | SPD2-US-070-320 | 3037844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |