MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; SUPRARENAL AORTA UNI-ILIAC

Model Number	A28-28/C75-O20 V
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the patient had an initial procedure on (b)(6) 2015 with a bifurcated device and suprarenal aortic extension.Upon follow up, computed tomography (ct) from (b)(6) 2016 showed the suprarenal aortic extension had unintentional movement, causing a potential type 1a endoleak.On (b)(6) 2016, the physician implanted a suprarenal aortic extension to seal the endoleak.The patient is in stable condition.

• Brand Name: AFX
• Common Device Name: SUPRARENAL AORTA UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5851930
• Report Number: 2031527-2016-00386
• Device Sequence Number: 796821
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)151113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2015
• Device Model Number: A28-28/C75-O20 V
• Device Lot Number: 1252019-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2016
• Initial Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR