MAUDE Adverse Event Report: ENDOLOGIX AFX; AFX INTRODUCER SYSTEM II

Model Number	S17-45
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Codes	Failure of Implant (1924); Rupture (2208)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
To date the incident device 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.
Event or Problem Description
During the initial implant procedure of a bifurcated stent the patient had an intraoperative right iliac rupture.The treatment of the ruptured iliac was not initially reported to endologix, it is unknown if any additional non-endologix stents were implanted.The patient is reported to be in stable condition post procedure.To date there have been no additional adverse events reported for this patient.
Additional Manufacturer Narrative
Based on the information available the root cause of the reported event is likely due to user and or anatomically related issues.Clinical review identified there was suboptimal positioning of the infrarenal cuff, and there was moderate angulation of the infrarenal aorta.The device was not returned, therefore no physical evaluation was completed.

• Brand Name: AFX
• Common Device Name: AFX INTRODUCER SYSTEM II
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 6689324
• Report Number: 2031527-2017-00415
• Device Sequence Number: 16460529
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)200123
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

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: 01/23/2020
• Device Model Number: S17-45
• Device Lot Number: 1645526-034
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 07/06/2017
• 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: Required Intervention
• Patient Age: 71 YR