FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 1131932
·
Received August 22, 2008
Report
- Report Number
- 1820334-2008-00497
- Event Type
- Injury
- Date Received
- August 22, 2008
- Date of Event
- July 25, 2008
- Report Date
- July 25, 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 EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE WITH LUNG DISEASE AND PREVIOUS HISTORY OF HYPERTENSION HAD A SUITABLE ANATOMIC FORM FOR AAA REPAIR AND UNDERWENT THE EVAR PROCEDURE IN 2008. THE PROCEDURE WENT AS LABELED BUT UPON DEPLOYMENT OF THE CONTRALATERAL ILIAC LEG GRAFT, BLOOD LEAKED FROM THE HEMOSTATIC VALVE DURING INSERTION AND DILATION OF ANOTHER MFR'S BALLOON CATHETER. THE PHYSICIAN CUT THE SHAFT OF THE DELIVERY SYS BUT THE LEAKAGE DID NOT STOP. THE PT'S TOTAL HEMORRHAGE VOLUME WAS 800CC. A BLOOD TRANSFUSION WAS LIKELY TO BE PERFORMED AT A LATER DATE. AT THIS TIME THE PT'S HEALTH STATUS IS UNK.
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 | F2174166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |