MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number	BA25-120/I20-40
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2016
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 the patient had an initial procedure on (b)(6) 2015 with a bifurcated stent and two suprarenal aortic extensions.A follow up computed tomography (ct), showed a kink in the bifurcated stent with no endoleak present.On (b)(6) 2016 the physician elected to implant two additional suprarenal aortic extensions to cover the kinked area and increase overlap into the neck.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6062420
• Report Number: 2031527-2016-00500
• Device Sequence Number: 16342088
• Product Code: MIH
• UDI-Device Identifier: 00818009011985
• UDI-Public: (01)00818009011985(17)171212
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2017
• Device Model Number: BA25-120/I20-40
• Device Lot Number: 1283306-029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUPRARENAL AORTA UNI-ILIAC- 1202763-028; SUPRARENAL AORTA UNI-ILIAC- 1252023-006
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR