FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 3063359
·
Received March 28, 2013
Report
- Report Number
- 1820334-2013-00144
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Report Date
- March 7, 2013
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - PT OUTCOME WAS NOT PROVIDED BY THE REPORTER. (B)(4) - OCCLUSION IS LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE UNDERWENT EVAR ON (B)(6) 2013. THE PHYSICIAN PLACED A FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS. UPON THE 1-6 MONTH FOLLOWING UP CLINICAL ASSESSMENT, EXTERNAL COMPRESSION WAS OBSERVED FOR THE LEFT ILIAC GRAFT. PT OUTCOME - UNK AS NOT PROVIDED BY THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129132 | ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 3816938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |