FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 1083279
·
Received July 25, 2008
Report
- Report Number
- 1820334-2008-00449
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- March 28, 2008
- Report Date
- March 28, 2008
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE WITH A PREVIOUS HISTORY OF HYPERTENSION, SIGMOID COLON CANCER, AND LIVER CANCER HAD A PRE-DIAGNOSIS OF ILIAC ARTERY ANGULATION EXCEEDING 90 DEGREES WAS DETERMINED TO HAVE SUITABLE FORM FOR AAA REPAIR. IN 2008, A POST-DEPLOYMENT ANGIOGRAM NOTED A KINK IN THE CONTRALATERAL ILIAC LEG GRAFT. A PTA BALLOON CATHETER WAS USED TO INFLATE THE KINK SITE AND A SELF-EXPANDING STENT OF ANOTHER MFR WAS ALSO PLACED AT THE AREA. THE KINK WAS RESOLVED. PT OUTCOME IS UNK AT THIS TIME.
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 | F2136128 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |