MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-80/I20-40
Medical Device Problem Codes	Collapse (1099); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2017
Type of Reportable Event	Malfunction
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.
Event or Problem Description
During the initial procedure, while deploying the main body it was discovered through angio that the main body was placed above the renals and the iliac limbs were much higher compared to the original position.The physician attempted to snare the limbs to place it back in the iliac but the limbs collapse.A medtronic aortomonoiliac was placed and the physician performed a femoro-femora bypass to successfully resolve the issue.Patient is reported to be doing well.

• Brand Name: AFX
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7119766
• Report Number: 2031527-2017-00672
• Device Sequence Number: 19057439
• Product Code: MIH
• UDI-Device Identifier: 00818009012210
• UDI-Public: (01)00818009012210(17)200327
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/27/2020
• Device Model Number: BA25-80/I20-40
• Device Lot Number: 1668747009
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/14/2017
• 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: Other