FDA Adverse Event
Injury
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GARFT BIFURCATED MAIN BODY
MDR report key: 1193303
·
Received October 7, 2008
Report
- Report Number
- 1820334-2008-00558
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- September 8, 2008
- Report Date
- September 8, 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
EVENT EVAL - 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. OVER TIME DUE TO THE PT HAVING A VERY ANGULATED AND CONICAL NECK AND THE SAC INCREASING, THE FLEX MAIN BODY MIGRATED. THE PRESSURE WAS ALSO INCREASED BY CARDIOMEMS. THE PHYSICIAN PLACED A RENU CUFF AND THE PT IS DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH FLEX AAA ENDOVASCULAR GARFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC. | NA | 1929058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |