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

Model Number	A28-28/C75-O20 V
Medical Device Problem Codes	Fitting Problem (2183); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident sample has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device has not been returned.
Event or Problem Description
Patient initially implanted with a bifurcated stent, a suprarenal aortic extension, and a limb extension on (b)(6) 2016.During the initial implant when deploying the aortic extension the implant was not the correct size and the physician attempted to remove the device.During the removal of the device the physician damaged the left femoral artery.The physician repaired the artery and the patient is in stable condition.

• Brand Name: AFX
• Common Device Name: SUPRARENAL AORTA UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5621280
• Report Number: 2031527-2016-00181
• Device Sequence Number: 20937
• Product Code: MIH
• UDI-Device Identifier: 00818009013583
• UDI-Public: (01)00818009013583(17)81211
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/30/2016

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: 12/11/2018
• Device Model Number: A28-28/C75-O20 V
• Device Lot Number: 1252037-021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2016
• Initial Report FDA Received Date: 04/29/2016
• 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: 61 YR