FDA Adverse Event
Injury
Summary report: N
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 3940852
·
Received July 8, 2014
Report
- Report Number
- 1820334-2014-00320
- Event Type
- Injury
- Date Received
- July 8, 2014
- Date of Event
- June 19, 2014
- Report Date
- June 20, 2014
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE PATIENT HAD AN EVAR PROCEDURE ON (B)(6) 2008. AFTER THE PROCEDURE, THE PHYSICIAN FOUND OUT THE ANEURYSM WAS STILL GROWING DURING THE FOLLOW UP, BUT HE COULD NOT FIND ANY OBVIOUS ENDOLEAK. HE FOUND TYPE I ENDOLEAK IN 2013, SO HE PUT A BODY EXTENSION ON (B)(6) 2013. HOWEVER, THE ANEURYSM STILL BECAME BIGGER AND HE COULD NOT FOUND OUT THE SOME ENDOLEAK VIA CT. HE THOUGHT THAT THIS IS THE TYPE II ENDOLEAK, SO HE DECIDED TO DO THE OPEN SURGERY FOR THIS PATIENT ON (B)(6) 2014. HE OPENED PATIENT'S ABDOMEN AND USED THE TISSUE GLUE TO HOMEOSTASIS. THERE IS NO ENDOLEAK AND PATIENT'S CONDITION IS FINE NOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 395544 | ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 1995569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |