FDA Adverse Event
Malfunction
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 2132384
·
Received June 14, 2011
Report
- Report Number
- 1820334-2011-00310
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- May 23, 2011
- Report Date
- May 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 EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE PATIENT UNDER WENT AAA REPAIR ON (B)(6) 2011. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR. THE PROCEDURE WAS CONDUCTED AS LABELED AND A MAINBODY AND TWO ILIAC LEGS WERE PLACED AND THE FINAL CONFIRMATORY ANGIOGRAPHY SHOWED TYPE IV ENDOLEAK FROM THE PART BETWEEN THE THIRD STENT AND THE LIMB OF THE MAINBODY. IT BECAME BETTER BY ADDITIONAL PLACEMENT OF A BODY EXTENSION BUT STILL PERSISTED. THE PHYSICIAN DECIDED TO TAKE A WAIT AND SEE APPROACH. THE PATIENT'S CONDITION IS UNKNOWN AS NOT PROVIDED BY REPORTER. IMAGES AND ACT LEVEL WILL BE PROVIDED.
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 | F2615440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR |