FDA Adverse Event
Injury
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 2903563
·
Received December 31, 2012
Report
- Report Number
- 1820334-2013-00026
- Event Type
- Injury
- Date Received
- December 31, 2012
- Report Date
- December 14, 2012
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT UNDERWENT EVAR ON (B)(6) 2009. THE PHYSICIAN PLACED ONE FLEX MAIN BODY, THREE ILIAC LEG GRAFTS, AND ONE MAIN BODY EXTENSION. UPON FOLLOW UP CT SCAN RECENTLY, THERE IS NOW NOTED A TYPE 3 ENDOLEAK. THE PHYSICIAN DESCRIBES IT AS A SEPARATION OF THE ILIAC LEG FROM THE MAIN BODY. THE PATIENT IS BEING REFERRED TO ANOTHER HOSPITAL. AT THIS TIME NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 2276784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |