FDA Adverse Event
Injury
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 2193352
·
Received July 28, 2011
Report
- Report Number
- 1820334-2011-00388
- Event Type
- Injury
- Date Received
- July 28, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 29, 2011
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
OCCLUSION IS LABELED IN THE IFU. EVENT STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR. THE PROCEDURE WAS CONDUCTED AS LABELED EXCEPT FOR CONDUCTING MAIN BODY PROXIMAL DEPLOYMENT BEFORE CONTRALATERAL (LEFT IN THIS CASE) ILIAC WIRE GUIDE PLACEMENT. THE FINAL CONFIRMATORY ANGIOGRAPHY CONFIRMED THAT THERE IS NO BLOOD FLOW TO LEFT INTERNAL ILIAC ARTERY. THE LEFT IIA WAS OCCLUDED BY LEFT ILIAC LEG. NO ADD'L TREATMENT WAS CONDUCTED AND THE PROCEDURE WAS COMPLETED. NO PT OUTCOME PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | F2644166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other| S |