MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; INFRARENAL AORTO UNI-ILIAC

Model Number	A28-28/C55
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains 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 implant on (b)(6) 2015 with a bifurcated and infrarenal aortic extension.Subsequently, during a follow up visit on (b)(6) 2016, computed tomography revealed a type 1a endoleak.The wedge of thrombus present during initial implant had resolved, contributing to the 1a leak.The physician sealed the leak on (b)(6) 2016 by implanting a suprarenal aortic extension.The patient is in stable condition.
Additional Manufacturer Narrative
At the completion of the investigation, the clinical evaluation was able to confirm the reported event.The clinical assessment was based on adequate medical records, and no patient images.A manufacturing or design issue has not been identified or suspected based on the evaluation of the reported event.The root cause of the reported event is unknown, there is not enough information to determine the root cause of the reported event.Limited patient records were available and the device was not returned for evaluation.Due to limited patient records potential contributing factors are not able to be determined.

• Brand Name: AFX
• Common Device Name: INFRARENAL AORTO UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5764991
• Report Number: 2031527-2016-00326
• Device Sequence Number: 16143471
• Product Code: MIH
• UDI-Device Identifier: 00818009010278
• UDI-Public: (01)00818009010278(17)170924
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2016

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: Physician
• Device Expiration Date: 09/24/2017
• Device Model Number: A28-28/C55
• Device Lot Number: 1267187-006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/03/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2016
• Supplement Report FDA Received Date: 09/27/2016
• 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