FDA Adverse Event
Death
Summary report: N
SPIDERFX EMBOLIC PROTECTION DEVICE
MDR report key: 1227126
·
Received October 29, 2008
Report
- Report Number
- 2183870-2008-00158
- Event Type
- Death
- Date Received
- October 29, 2008
- Date of Event
- February 16, 2008
- Report Date
- October 16, 2008
- 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
PLEASE REFERENCE MDR 2183870-2008-00157 FOR PROTEGE RX USED IN THIS PROCEDURE.
Description of Event or Problem · 1
PT ENROLLED INTO THE TRIAL. RENAL INSUFFICIENCY REPORTED AS WELL AS A MAJOR HEMORRHAGIC STROKE. PT HAD SLURRED TO GARBLED SPEECH, BLANK STARE, RIGHT SIDED FACIAL DROOP. A CT SCAN WHICH SHOWED A "LARGE INTRAPARENCHYMAL HEMORRHAGE" IN RIGHT SUPERIOR PARIETAL LOBE. ACTION TAKEN INCLUDED LABS, EXG, INTUBATION, VENTILATOR, AND MEDICATION CHANGE. PT EXPIRED IN 2008.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPIDERFX EMBOLIC PROTECTION DEVICE | NTE | EV3 INC. | SPD2-US-060-190 | 4000717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Death |