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

Model Number	BA28-80/I16-40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The root cause of the reported event is inconclusive.There were no manufacturing issues or device failures identified with the reported event.The device was not returned for further evaluation and a clinical evaluation was not able to identify an issue with the initial implanted devices.Devices remain implanted in the patient.
Event or Problem Description
Patient initially implanted with a bifurcated device and an infrarenal aortic extension on (b)(6) 2016.Physician elected not to place a limb extension during the initial procedure due to the tortuosity of the patients left common iliac.Patient came in for a follow up on (b)(6) 2016 an based on computed tomography (ct) the physician elected to implant the limb extension.The ct did not reveal any issues with the initially implanted devices.The patient is in stable condition.

• Brand Name: AFX
• Common Device Name: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 5729467
• Report Number: 2031527-2016-00277
• Device Sequence Number: 13580848
• Product Code: MIH
• UDI-Device Identifier: 00818009010025
• UDI-Public: (01)00818009010025(17)180807
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 03/14/2016

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: 08/07/2018
• Device Model Number: BA28-80/I16-40
• Device Lot Number: 1371054-023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2016
• Initial Report FDA Received Date: 06/16/2016
• 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: 75 YR