FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ILIAC LEG DELIVERY SYSTEM
MDR report key: 1062737
·
Received June 17, 2008
Report
- Report Number
- 1820334-2008-00304
- Event Type
- Injury
- Date Received
- June 17, 2008
- Date of Event
- May 19, 2008
- Report Date
- May 19, 2008
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE UNDERWENT INITIAL AAA PROCEDURE IN 2007. ONE FLEX MAIN BODY, THREE ILIAC LEG GRAFTS, AND ONE MAIN BODY EXTENSION (USED IN THE ILIAC) WERE PLACED. FOLLOW-UP CT'S INDICATED DISTAL TYPE I ENDOLEAKS ON BOTH SIDES. IN 2008, THE PHYSICIAN EMBOLIZED THE HYPOGASTRIC ARTERY ON THE PT'S LEFT SIDE AND PLACED AN ADDITIONAL ILIAC LEG GRAFT TO EXTEND ILIAC ARTERY. ON THE PT'S RIGHT SIDE, (SEE 1820334-2008-00305) TWO ILIAC LEG GRAFTS WERE PLACED TO LAND IMMEDIATELY INFERIOR TO THE HYPOGASTRIC ARTERY TO GAIN AN ADEQUATE SEAL. A COMPLETION ANGIOGRAM INDICATED THAT BOTH ENDOLEAKS WERE RESOLVED. PT OUTCOME WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH AAA ILIAC LEG DELIVERY SYSTEM | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 1759658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |