MAUDE Adverse Event Report: ENDOLOGIX, INC. AFX2; AFX2 BIFURCATED STENT GRAFT

Model Number	BEA25-80/I13-40
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Occlusion (1984)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation and remains implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.Device iteration is afx2.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx2 abdominal aortic aneurysm stent.Approximately one (1) year post initial procedure, the patient presented with a left-side graft limb occlusion.However, the exact date of event is unknown.The physician plans to re-intervene but surgery has not been scheduled.As of date, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
Clinical assessment was completed based on the received medical records.The left iliac occlusion complaint is confirmed.The complaint is most likely user related due to the pre-existing aorto-iliac occlusive disease (off label condition) as well as the right iliac diameter of 7.5mm and left iliac diameter of 9.1mm (should be 10-23mm) which also likely contributed to this event.Procedure related harms for this event could not be determined.The final patient status was not reported.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted; therefore, no evaluation was completed.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.Device iteration is afx2.Corrections: g1,2: contact office- name has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX2
• Common Device Name: AFX2 BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• MDR Report Key: 9136415
• Report Number: 2031527-2019-00440
• Device Sequence Number: 19629572
• Product Code: MIH
• UDI-Device Identifier: 00818009014788
• UDI-Public: (01)00818009014788(17)190711
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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: 07/11/2019
• Device Model Number: BEA25-80/I13-40
• Device Lot Number: 1956286-001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 04/29/2020
• 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
• Patient Age: 49 YR