FDA Adverse Event
Injury
Summary report: N
POWERLINK SYSTEM
MDR report key: 2062880
·
Received April 19, 2011
Report
- Report Number
- 2031527-2011-00021
- Event Type
- Injury
- Date Received
- April 19, 2011
- Date of Event
- March 22, 2011
- Report Date
- April 26, 2011
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
USE OF DEVICE WITH RUPTURED ANEURYSMS CONSIDERED OFF-LABEL PER INSTRUCTIONS FOR USE.
Additional Manufacturer Narrative · 1
REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.
Description of Event or Problem · 1
ON (B)(6) 2011 PATIENT PRESENTED WITH A RUPTURED AORTIC ANEURYSM (OFF LABEL). IMPLANT OF A (B)(4) BIFURCATED DEVICE AND A 25 MM SUPRARENAL AORTIC EXTENSION WAS SUCCESSFUL AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE NEXT DAY A CT SCAN REVEALED A TYPE III ENDOLEAK BETWEEN THE BIFURCATED DEVICE MAIN BODY AND THE AORTIC EXTENSION. ON (B)(6) 2011 AN AORTIC STENT WAS PLACED WHICH RESOLVED THE ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | SUPRARENAL PROXIMAL EXTENSION STENT GRAFT | MIH | ENDOLOGIX, INC. | 25-25-95RL | W11-0345-018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |