FDA Adverse Event
Injury
Summary report: N
POWERLINK SYSTEM
MDR report key: 1131901
·
Received August 20, 2008
Report
- Report Number
- 2031527-2008-00045
- Event Type
- Injury
- Date Received
- August 20, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 18, 2008
- Manufacturer
- ENDOLOGIX, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.
Description of Event or Problem · 1
PT PRESENTED WITH AN 80 DEGREE ANGLE IN THE AORTIC NECK; IMPLANT OF A BIFURCATED DEVICE, TWO PROXIMAL CUFFS AND TWO LIMB EXTENSIONS IN 2007. INITIALLY, THERE WAS GOOD SEAL, HOWEVER, OVER THE COURSE OF ABOUT SIX MONTHS, THE PT DEVELOPED A PROXIMAL TYPE I ENDOLEAK. THE INITIAL CUFF HAD MIGRATED DISTALLY, ABOUT 1 CM BELOW WHERE IT WAS ORIGINALLY PLACED, DUE TO THE ANGULATION. IN 2008, THE PT WAS BROUGHT IN TO TREAT THE ENDOLEAK WITH AN ADDITIONAL PROXIMAL CUFF AND THERE WAS NO LEAK PRESENT AT THE END OF THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POWERLINK SYSTEM | INFRARENAL CUFF STENT GRAFT | MIH | ENDOLOGIX, INC. | 28-28-55L | W07-1411 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |