FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ILIAC LEG GRAFT
MDR report key: 1050309
·
Received May 22, 2008
Report
- Report Number
- 1820334-2008-00284
- Event Type
- Injury
- Date Received
- May 22, 2008
- Date of Event
- April 24, 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
STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
IN 2008, A MALE PT UNDERWENT INITIAL AAA REPAIR WITH ONE MAIN BODY GRAFT AND TWO ILIAC LEG GRAFTS. DUE TO THE PT'S TORTUOUS ANATOMY, OVER TIME A TYPE I ENDOLEAK DEVELOPED. AN ILIAC LEG GRAFT WAS PLACED ON APPROX THREE AND A HALF MONTHS PRIOR TO EVENT DATE TO SUCCESSFULLY RESOLVE THE ENDOLEAK. KNOWN FOUR DAYS EARLIER, DEVICE WAS PLACED FOUR DAYS LATER. ENDOLEAK RESOLVED. PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH AAA ILIAC LEG GRAFT | MIH ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 1731847 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |