FDA Adverse Event
Injury
Summary report: N
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
MDR report key: 1918351
·
Received December 1, 2010
Report
- Report Number
- 1820334-2010-00623
- Event Type
- Injury
- Date Received
- December 1, 2010
- Date of Event
- November 3, 2010
- Report Date
- November 4, 2010
- Manufacturer
- COOK INC
- Product Code
- MIH
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - CONVERSION TO OPENED SURGICAL REPAIR, (B)(4) - ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
A MALE PT UNDERWENT ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2008. THE PHYSICIAN IMPLANTED A FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS. THERE WERE NO REPORTED COMPLICATIONS. ON (B)(6) 2010, THE PT HAD ALL DEVICES EXPLANTED AND WAS CONVERTED TO OPEN REPAIR DUE TO CONTINUED FOLLOW-UPS. IT WAS NOTED CONTINUED SAK GROWTH. THE PT HAD A SYMPTOMATIC EMERGENCY ROOM VISIT THAT LED TO THE EXPLANT.
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 | 1985305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |