MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX; INFRARENAL AORTO UNI-ILIAC

Model Number	A28-28/C95 V
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/19/2015
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.
Event or Problem Description
It was reported the patient had an initial procedure on (b)(6) 2015 with a bifurcated and a infrarenal aortic extension.Patient came in emergently for critical limb ischemia on (b)(6) 2015.Computed tomography angiogram (cta) showed the patient had a kink in the implanted endograft.The physician elected to implant an infrarenal aortic extension to resolve the issue.Post procedure the patient was in stable condition.

• Brand Name: AFX
• Common Device Name: INFRARENAL AORTO UNI-ILIAC
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5438509
• Report Number: 2031527-2016-00059
• Device Sequence Number: 18945713
• Product Code: MIH
• UDI-Device Identifier: 00818009013521
• UDI-Public: (01)00818009013521(17)171013
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2015

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: 10/13/2017
• Device Model Number: A28-28/C95 V
• Device Lot Number: 1252151-018
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2015
• Initial Report FDA Received Date: 02/16/2016
• 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: 72 YR