MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I16-40
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx iliac limb, two (2) afx vela suprarenal¿s, and a vela infrarenal.Approximately one and a half (1.5) years post initial procedure, the patient presented with a type ib endoleak.The physician plans to place a limb extension.The patient is stable and is currently being monitored.
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 will be requested for further evaluation by the clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2 h3 other text: device remains implanted.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination needed for device identification shows the device to have been properly manufactured and released in accordance with the device master record.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because it remains implanted.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows that the type ib endoleak of the left common iliac artery complaint is confirmed.This is consistent with the reported adverse event/incident.The complaint is likely anatomy related.The inferior stent margin of the left common iliac artery was sitting in a 61.6° angulation creating poor stent to wall apposition.This likely caused the type ib endoleak.There was a pre existing rupture at the index procedure which is a cautionary product use condition.Procedure related harms could not be determined.The final patient status was reported as stable pending reintervention.No additional investigation of this reported adverse event/incident is planned.However, should additional information relevant to the investigation outcome become available, a follow-up report will be submitted.Endologix will continue to monitor this and similar adverse events/incidents.Corrections: b2: outcomes attributed to ae has been updated.B5: describe event or problem has been updated.E1: physician first name has been updated.E1: physician last name has been updated.E1: remove physician email.G3: date received by manufacturer has been updated.H6: impact code: remove code 4614.H6: result code: remove code 3233.H6: conclusion code: remove code 11.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2023 with the implant of an afx2 bifurcated stent graft, an afx iliac limb, two afx vela suprarenal's, and an afx vela infrarenal.Routine follow-up on (b)(6) 2024 identified a type ib endoleak on the left side.Intervention was completed on (b)(6) 2025.The left common iliac artery with two ovation ix extenders.The type 1b endoleak was successfully resolved and the patient was discharged home the next day.
Additional Manufacturer Narrative
Corrections: b6: relevant tests and lab data has been updated.G3: date received by manufacturer has been updated.

• 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 ; 8009832284
• MDR Report Key: 21125139
• Report Number: 3011063223-2025-00007
• Device Sequence Number: 18038157
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)240628
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2024

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: 06/28/2024
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 2483803006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 03/17/2025; 07/11/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 06/04/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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: AFX LIMB STENT GRAFT, LOT # 2421054004.; AFX VELA INFRARENAL, LOT # 2368133003.; AFX VELA SUPRARENAL, LOT # 2473890001; AFX VELA SUPRARENAL, LOT # 2495983013.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Unknown