MAUDE Adverse Event Report: Endologix AFX2; Bifurcated Stent Graft

Model Number	BEA22-90/I16-30
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with implantation of an afx2 bifurcated stent graft and an ovation ix extender on (b)(6) 2019.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.During routine follow-up on (b)(6) 2026, a type 1b endo leak along with enlargement of the left common iliac aneurysm and abdominal aortic aneurysm were identified.Intervention occurred on (b)(6)2026 with implantation of an ovation ix iliac limb and an afx vela infrarenal.During the intervention, a left iliac type ib endo leak was confirmed originating from a gore vbx (non-endo logix) stent that was distal to the afx limb.An 80¿90% lesion of the external iliac artery (eia) was also identified distal to the vbx stent.The ovation ix iliac limb was implanted in an antegrade fashion from the contralateral side and extended to the external iliac artery.There was no type ia endoleak visible; however, it was the physician¿s preference to implant a 25x75 afx infrarenal cuff.The patient was reported to be recovering well.
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Patient medical records and imaging studies have been requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted upon completing of clinical evaluation.

• Brand Name: AFX2
• Common Device Name: Bifurcated Stent Graft
• Manufacturer (Section D): Endologix; 2 musick; irvine CA 92618
• Manufacturer (Section G): Endologix; 2 musick; ,; irvine CA 92618
• Manufacturer Contact: gary kirchgater ; 2 musick; ,; irvine, CA 92618 ; +1(800)983-2284
• MDR Report Key: 50144704
• Report Number: 3011063223-2026-00095
• Device Sequence Number: 15733211
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)181025
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2026

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: 10/25/2020
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 1752813006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Gore VBX Stent (Non-Endologix); Ovation IX Extender, Lot # FS110618-26
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male