FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 1170529
·
Received September 11, 2008
Report
- Report Number
- 1820334-2008-00550
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- June 16, 2008
- Report Date
- June 16, 2008
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NO
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A WITH AN AORTA THAT WAS NOT VERY CURVED, UNDERWENT AAA REPAIR IN 2008. WHEN THE MAIN BODY OF THE ZENITH DEVICE WAS IN PLACE, AND THEY WERE ABOUT TO PULL THE RELEASE WIRE TO THE TOP CAP IT HAD STUCK. THEY COULD NOT PULL WITHOUT BENDING THE WHOLE SYSTEM. UPON INQUIRY, ONE OF THE PHYSICIANS RECEIVED A RECOMMENDATION FROM ANOTHER EXPERIENCED ENDOVASCULAR TEAM TO PULL HARDER. EVENTUALLY THE WIRE LET GO OF THE TOP CAP AND THEY WERE ABLE TO FINISH THE PROCEDURE. THE WIRE GUIDE USED DURING THIS PROCEDURE WAS A LUNDERQUIST WIRE. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 2069720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |