FDA Adverse Event
Injury
Summary report: N
AFX
MDR report key: 5992506
·
Received October 1, 2016
Report
- Report Number
- 2031527-2016-00465
- Event Type
- Injury
- Date Received
- October 1, 2016
- Date of Event
- August 11, 2016
- Report Date
- August 11, 2016
- Manufacturer
- ENDOLOGIX INC.
- Product Code
- MIH
- PMA / PMN Number
- P040002
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION, THEY REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICES REMAIN IMPLANTED IN THE PATIENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2011 WITH A BIFURCATED STENT AND SUPRARENAL AORTIC EXTENSION. ON (B)(6) 2016 A FOLLOW UP FOUND A POTENTIAL TYPE 3A OR TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO RELINE THE INITIAL DEVICES AND IMPLANTED AND OVATION MAIN BODY AND TWO LIMB STENTS. THE PATIENT IS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643962 | AFX | BIFURCATED | MIH | ENDOLOGIX INC. | BA22-80/I13-40 | W11-4380-014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | SUPRARENAL AORTA UNI-ILIAC- (B)(4) |