FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 1241621
·
Received November 21, 2008
Report
- Report Number
- 1820334-2008-00664
- Event Type
- Injury
- Date Received
- November 21, 2008
- Report Date
- October 29, 2008
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE WITH TORTUOUS ANATOMY ON BOTH SIDES UNDERWENT INITIAL AAA REPAIR IN 2008. THE PHYSICIAN PLACED ONE MAIN BODY AND TWO ILIAC LEG GRAFTS. SOME TIME LATER, THE PT DEVELOPED A KINK ON THE RIGHT SIDE. AT THAT TIME, THE PHYSICIAN PLACED ANOTHER STENT ON THE RIGHT SIDE AND DILATED TO 12MM. THE PT WAS STILL HAVING SOME ISSUES AND THE PHYSICIAN REALIZED THAT SOMETHING WAS GOING ON AT THE GRAFT BIFURCATION (1820334-2008-00665); SO ON APPROX SIX MONTHS LATER, THE PHYSICIAN BUILT UP THE BIFURCATION OF THE PREEXISTING GRAFT WITH TWO LEG EXTENSIONS ALSO DECIDING TO GO AHEAD AND EXTEND THE SEAL ZONE ON THE RIGHT SIDE WITH ANOTHER LEG GRAFT. NO IMAGES ARE AVAILABLE AT THIS TIME. PT IS DOING FINE.
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 | 1734387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |