FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 2220506
·
Received July 18, 2011
Report
- Report Number
- 1820334-2011-00386
- Event Type
- Malfunction
- Date Received
- July 18, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 24, 2011
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
AN (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR, AND THE PROCEDURE WAS CONDUCTED AS LABELED. AFTER REPLACEMENT OF THE DEVICES, FINAL CONFIRMATORY ANGIOGRAPHY AFTER BALLOONING CONFIRMED TYPE IV ENDOLEAK. THE PHYSICIAN DID NOT CONDUCT ANY FURTHER TREATMENT FOR THE ENDOLEAK. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PTS.
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 | F2619281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR |