FDA Adverse Event
Injury
Summary report: N
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
MDR report key: 2954208
·
Received February 5, 2013
Report
- Report Number
- 1820334-2013-00073
- Event Type
- Injury
- Date Received
- February 5, 2013
- Report Date
- January 18, 2013
- Manufacturer
- COOK, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A (B)(6) MALE UNDERWENT INITIAL EVAR ON (B)(6) 2012. THE PHYSICIAN PLACED ONE FLEX MAIN BODY AND TWO ILIAC LEGS WITH SPIRAL-Z TECHNOLOGY. UPON FOLLOW UP IT WAS REPORTED THAT THE PATIENT HAD SIGNIFICANT CALCIFICATION. THE LEFT COMMON ILIAC OCCLUDED AND THE PHYSICIAN WENT IN AND HAD TO DO A FEM FEM BYPASS ON THE PATIENT ON (B)(6) 2013. PATIENT IS IN STABLE CONDITION AND NO ADVERSE EFFECTS HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 48076 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK, INC. | NA | 3554140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention |