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

Model Number	A34-34/C100-O20 V
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670); Malposition of Device (2616); Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/05/2016
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, a suprarenal aortic extension and two infrarenal aortic extensions on (b)(6) 2016.During the initial implant one of the proximal extensions was placed in a suboptimal position resulting in intraoperative stent migration leading to a type 1a endoleak.The physician implanted a competitor stent to seal the leak.The endoleak was not completely sealed following the initial implant procedure.The physician elected to monitor the patient.The patient had two ultra sounds post implant and the physician believes the leak is sealed.The patient is stable.

• Brand Name: AFX
• Common Device Name: SUPRARENAL AORTA UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5636087
• Report Number: 2031527-2016-00199
• Device Sequence Number: 142350
• Product Code: MIH
• UDI-Device Identifier: 00818009014160
• UDI-Public: (01)00818009014160
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2019
• Device Model Number: A34-34/C100-O20 V
• Device Lot Number: 1464243-21
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2016
• Initial Report FDA Received Date: 05/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR