FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ENDOVASCUALR GRAFT ILIAC LEG
MDR report key: 1241612
·
Received November 21, 2008
Report
- Report Number
- 1820334-2008-00670
- Event Type
- Injury
- Date Received
- November 21, 2008
- Date of Event
- October 31, 2008
- Report Date
- October 31, 2008
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE WITH A STRAIGHT FORWARD ANATOMY, UNDERWENT INITIAL AAA REPAIR IN EARLY 2007. ONE MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. DURING INITIAL IMPLANT, THE PT'S ILIAC MEASURED 18 AND ON F/U IT MEASURED 20-21. PHYSICIAN SUSPECTED AN ENDOLEAK OR CONTINUED ANEURYSM GROWTH, SO IN 2008, THE PHYSICIAN PLACED AN ADD'L ILIAC LEG GRAFT DOWN TO COVER MORE OF THE ILIAC WITH SUCCESS. PT IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH AAA ENDOVASCUALR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 1779498 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |