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

Model Number	BA22-60/I16-40
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	07/07/2016
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.
Event or Problem Description
It was reported that during the initial procedure on (b)(6) 2016, physician noted the aneurysmal right common iliac artery had moderate calcification and moderate tortuosity and the left external iliac artery was narrow with calcification.During deployment of the bifurcated device, it was difficult to deploy the contralateral side due to patient anatomy.After deployment, procedure was completed, but physician noted that the leg was pulseless and that blood circulation was not made at the periphery.This was due to a dissection in the left external iliac artery that was resolved by implanting a non-endologix stent.Physician elected to also implant a limb extension to better seal the left common iliac artery, which was also difficult to deploy due to device being caught by an edge of the contralateral limb of the bifurcated device.Physician was able to deploy the limb extension and complete the procedure.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: 5871945
• Report Number: 2031527-2016-00394
• Device Sequence Number: 19125546
• Product Code: MIH
• UDI-Device Identifier: 00818009010193
• UDI-Public: (01)00818009010193(17)180903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PO40002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

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: 09/03/2018
• Device Model Number: BA22-60/I16-40
• Device Lot Number: 1270771-012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 08/12/2016
• 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: 86 YR