MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; SUPRARENAL AORTO 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	04/04/2016
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
Patient initially implanted with a bifurcated stent and an infrarenal aortic extension on (b)(6) 2013.On (b)(6) 2014 the patient had an additional suprarenal aortic extension placed to correct a type 1a endoleak.On (b)(6) 2016 computed tomography (ct) showed an unknown endoleak.On (b)(6) 2016 an angiogram confirmed a type 1a endoleak.The subsequent endovascular procedure was delayed due to the poor health of the patient.The patient has been scheduled for an intervention which has not taken place at this time.

• Brand Name: AFX
• Common Device Name: SUPRARENAL AORTO UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5834928
• Report Number: 2031527-2016-00377
• Device Sequence Number: 16235779
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2016

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: 01/24/2015
• Device Model Number: A28-28/C75-O20 V
• Device Lot Number: 1203992-016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2016
• Initial Report FDA Received Date: 07/29/2016
• 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: 86 YR