MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A25-25/C95 V
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.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 buckled stent with stenosis and additional endovascular procedure complaints are unconfirmed.This is not consistent with the reported adverse event/incident.The patient was readmitted on january 6 and discharged home on january 10 with diagnoses of sepsis and left upper lobe pneumonia.The sepsis and pneumonia were discovered during review of the discharge summary dated 10 january 2026.This was determined to be a non¿device-related infection on nuclear medical white blood cell imaging; however, it is unclear whether this represents a procedure-related complication.The clinical assessment also determined that there was evidence to reasonably suggest readmission with sepsis (infection) and left upper lobe pneumonia occurred that was not included in the event as reported.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be determined.The final patient status was reported as home from the hospital.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.
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.Available patient medical records and imaging studies have been received for evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela suprarenal, an afx vela suprarenal and two ovation ix iliac limbs on (b)(6) 2025.The following day a follow-up computed tomography angiography (cta) showed that the vela infrarenal was bent over from the angle in the patient¿s neck and causing a stenosis.Intervention occurred on (b)(6) 2025 with implantation of vela infrarenal and vela suprarenal.Stenosis was fixed and patient is out of he hospital.

• Brand Name: AFX
• Common Device Name: VELA INFRARENAL
• 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: 24030667
• Report Number: 3011063223-2026-00003
• Device Sequence Number: 8969585
• Product Code: MIH
• UDI-Device Identifier: 00818009013507
• UDI-Public: (01)00818009013507(17)270925
• 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: 2025
• 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): 12/16/2025

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 Model Number: A25-25/C95 V
• Device Lot Number: 2848314002
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2024
• 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 VELA SUPRARENAL, LOT#: 2876789009.; AFX2 BIFURCATED STENT GRAFT, LOT#: 2880207001.; OVATION IX ILIAC LIMB, LOT#: FS030824-31.; OVATION IX ILIAC LIMB, LOT#: FS092325-25.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male