MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; BIFURCATED

Model Number	BA25-120/I20-40
Medical Device Problem Codes	Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/17/2016
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 procedure on (b)(6) 2016 with a bifurcated, an infrarenal aortic extension, and a limb stent graft.Subsequently, during a routine follow up, computed tomography revealed the patient had a type 1a endoleak.Physician implanted an infrarenal aortic extension to resolve the leak.Procedure was successful and patient is doing well.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5654998
• Report Number: 2031527-2016-00212
• Device Sequence Number: 20396
• Product Code: MIH
• UDI-Device Identifier: 00818009011985
• UDI-Public: (01)00818009011985(17)171212
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2016

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: 12/12/2017
• Device Model Number: BA25-120/I20-40
• Device Lot Number: 1283306-012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2016
• Initial Report FDA Received Date: 05/13/2016
• 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: 71 YR