FDA Adverse Event
Injury
Summary report: N
POWERLINK SYSTEM
MDR report key: 1933974
·
Received December 21, 2010
Report
- Report Number
- 2031527-2010-00140
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- December 3, 2010
- Report Date
- June 10, 2011
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- PMA / PMN Number
- P040002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
READS: W06-1481-002. SHOULD READ: W06-1484-002.
Additional Manufacturer Narrative · 1
REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. IT IS UNKNOWN IF THE PATIENT ANATOMY MET THE CRITERIA FOR INDICATIONS FOR USE. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE. NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
PATIENT IMPLANT ON (B)(6) 2007 OF A 28-16-140BL BIFURCATED DEVICE AND A 28-28-55L AORTIC EXTENSION. A 3 YEAR POST OPERATIVE FOLLOW UP REVEALED A TYPE III ENDOLEAK. ON (B)(6) 2010 THE PATIENT WAS TREATED WITH AN 34MM AORTIC EXTENSION AND AN AORTIC STENT TO CORRECT THE ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | INFRARENAL BIFURCATED STENT GRAFT | MIH | ENDOLOGIX, INC. | 28-16-140BL | W06-1484-002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |