FDA Adverse Event
Injury
Summary report: N
ZENITH FLEX AAA MAIN BODY DELIVERY SYSTEM
MDR report key: 1062740
·
Received June 17, 2008
Report
- Report Number
- 1820334-2008-00311
- Event Type
- Injury
- Date Received
- June 17, 2008
- Date of Event
- May 19, 2008
- Report Date
- June 18, 2008
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 REPAIR IN 2007. ONE FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. A TYPE LA ENDOLEAK DEVELOPED. THE PT'S ANATOMY IS NOT IDEAL BUT IN 2008, THE PHYSICIAN PLACED A RENU CUFF. ENDOLEAK IS RESOLVED FOR NOW AND PT IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH FLEX AAA MAIN BODY DELIVERY SYSTEM | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 1839779 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Required Intervention |