FDA Adverse Event
Death
Summary report: N
ENDOLOGIX POWERLINK SYSTEM
MDR report key: 1033412
·
Received April 23, 2008
Report
- Report Number
- 1033412
- Event Type
- Death
- Date Received
- April 23, 2008
- Date of Event
- April 3, 2008
- Report Date
- April 18, 2008
- Manufacturer
- ENDOLOGIX, INC
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ENDOLOGIX BIFURCATED GRAFT INTRODUCER FAILED DURING DEPLOYMENT AND BROKE. A PIECE OF THE DEVICE RETAINED IN AORTA CAUSING NEED TO CONVERT TO OPEN PROCEDURE. MASSIVE BLEEDING. PT ULTIMATELY EXPIRED IN SICU 24 HOURS POST-OP.
Description of Event or Problem · 1
ENDOLOGIX BIFURCATED GRAFT, (B)(4), SERIAL NUMBER (B)(4), INTRODUCER FAILED DURING DEPLOYMENT AND BROKE. A PIECE OF THE DEVICE RETAINED IN AORTA CAUSING NEED TO CONVERT TO OPEN PROCEDURE. MASSIVE BLEEDING. PT ULTIMATELY EXPIRED IN SICU 24 HOURS POST-OP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOLOGIX POWERLINK SYSTEM | BIFURCATED Y GRAFT | MIH | ENDOLOGIX, INC | 28-16-140BL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |