FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 1113156
·
Received August 12, 2008
Report
- Report Number
- 1820334-2008-00496
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- November 5, 2007
- Report Date
- June 16, 2008
- Manufacturer
- COOK INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE UNDERWENT EVAR IN 2004. ONE MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. THEN IN 2007, THE PT UNDERWENT ADDITIONAL PROCEDURE TO REPAIR POOR SEAL OF THE RIGHT ILIAC LIMB WITH SAC GROWTH FROM NATIVE VESSEL ENLARGEMENT AND SOME MIGRATION. ANOTHER MFR'S GRAFT WAS PLACED TO EXTEND THE SEAL TO THE CIA. PT IS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC. | NA | F1593291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |