FDA Adverse Event
Injury
Summary report: N
POWERLINK SYSTEM
MDR report key: 1878364
·
Received October 21, 2010
Report
- Report Number
- 2031527-2010-00124
- Event Type
- Injury
- Date Received
- October 21, 2010
- Date of Event
- September 22, 2010
- Report Date
- October 20, 2010
- Manufacturer
- ENDOLOGIX, INC
- Product Code
- MIH
- PMA / PMN Number
- P040002
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL DEVICES: INFRARENAL BIFURCATED STENT GRAFT. MODEL# 28-16-100BLS, LOT# W10-1171-001, EXPIRATION DATE: 05/01/2013. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE.
Description of Event or Problem · 1
PATIENT WAS IMPLANTED WITH A (B)(4) BIFURCATED DEVICE, A (B)(4) INFRARENAL AORTIC EXTENSION, AND A (B)(4) LIMB EXTENSION ON (B)(6) 2010. A (B)(6) 2010 FOLLOW-UP REVEALED A TYPE III ENDOLEAK BETWEEN THE BIFURCATED DEVICE MAIN BODY AND THE INFRARENAL AORTIC EXTENSION. ON (B)(6)2010, THE PATIENT WAS TREATED WITH A (B)(4) INFRARENAL AORTIC EXTENSION, WHICH RESOLVED THE TYPE III ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | INFRARENAL PROXIMAL EXTENSION STENT GRAFT | MIH | ENDOLOGIX, INC | 34-34-80LE | W10-1128-017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |