FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 1193290
·
Received October 7, 2008
Report
- Report Number
- 1820334-2008-00564
- Event Type
- Injury
- Date Received
- October 7, 2008
- Date of Event
- November 27, 2006
- Report Date
- September 12, 2008
- Manufacturer
- COOK INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVAL - STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A FEMALE UNDERWENT INITIAL AAA REPAIR IN 2003. ONE MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. THE PT HAD FOLLOWED UP PER PROTOCOL. IN 2006, THERE WAS SAC ENLARGEMENT, BUT NO TYPE I ENDOLEAK WAS SHOWN ON THE CT SCAN. THE PT WAS THEN TAKEN TO OR. THE PHYSICIAN THOUGHT THERE WAS A TYPE II ENDOLEAK AND NOTED RETROGRADE FILLING FROM THE RIGHT HYPO, SO HE PLACED ANOTHER MANUFACTURER'S LEG EXTENSION GRAFT INTO THE RIGHT EXTERNAL. ALSO DURING THE THE SAME YEAR PROCEDURE, HE NOTED A PROXIMAL LEAK, SO HE PLACED A MAIN BODY EXTENSION GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC. | NA | 1240436 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |