FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ILIAC LEG GRAFT
MDR report key: 1053316
·
Received May 27, 2008
Report
- Report Number
- 1820334-2008-00290
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- April 28, 2008
- Report Date
- April 28, 2008
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE WITH VERY SHORT COMMON ILIACS UNDERWENT INITIAL AAA REPAIR IN 2007. ONE FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. DUE TO THE ILIAC LEG GRAFT LANDING TOO CLOSE TO THE BIFURCATION, A TYPE I ENDOLEAK RESULTED. IN 2008, THE PHYSICIAN PLACED ANOTHER ILIAC LEG GRAFT ON THE LEFT SIDE TO RESOLVE THE ENDOLEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH AAA ILIAC LEG GRAFT | MIH ENDOVASCULAR GRAFT | MIH | COOK, INC. | NA | 1966018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |