MAUDE Adverse Event Report: ENDOLOGIX AFX; VELA INFRARENAL

Model Number	A25-25/C95 V
Medical Device Problem Codes	Off-Label Use (1494); Material Puncture/Hole (1504); Lack of Effect (4065)
Health Effect - Clinical Codes	Pain (1994); Clinical Endoleak (4843)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
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.H3 other text: device remains implanted.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2016 with implant of afx devices.On (b)(6) 2025, the patient presented emergently in pain.A computed tomography (ct) scan was taken and a type iiia endoleak in the afx vela suprarenal was observed.The physician elected to reline with a new afx vela suprarenal.The endoleak was resolved and the patient¿s final status was reported as okay.
Additional Manufacturer Narrative
A device evaluation will not be performed as the devices remain implanted in the patient.Medical images have been received, additional requests for medical records and imaging studies have been made.A follow-up report will be submitted upon completion of the clinical assessment.Corrections: b5: describe event or problem has been updated.D2: common device name has been updated.D4: model number has been updated.D4: lot # has been updated.D4: udi # has been updated.D6a: case date has been updated.D10: therapy dates row 1 has been updated.E1: physician first name has been updated.E1: physician last name has been updated.E1: hospital name has been updated.E1: hospital address line 1 has been updated.E1: hospital address line 2 has been updated.E1: hospital city has been updated.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2016 with implant of an afx bifurcated stent graft and an afx vela infrarenal.On (b)(6) 2025 the patient presented emergently in pain.A computed tomography (ct) scan was taken and a type iiia endoleak in the afx vela suprarenal was observed.The physician elected to reline with a new afx vela suprarenal.The endoleak was resolved and the patient¿s final status was reported as okay.
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 type iiia endoleak and additional endovascular procedure complaints are unconfirmed.This is not consistent with the reported adverse event/incident.The minimum access diameter on the right was 5.9mm, which is below the recommended minimum of = 6.5 mm making this off label; however, this is unlikely to have contributed to the reported event.Preoperative planning reported a suprarenal angulation of 41.2 degrees, which could have contributed to the reported type iiia endoleak; however, this cannot be conclusively determined.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 doing ok.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: b6: relevant tests and lab data has been updated g3: date received by manufacturer has been updated.H6: investigation type codes: remove code 4118 h6: result code: remove code 3233 h6: conclusion code: remove code 11.
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 type iiib endoleak and additional endovascular procedure complaints are unconfirmed.This is not consistent with the reported adverse event/incident.The minimum access diameter on the right was 5.9mm, which is below the recommended minimum of =6.5 mm making this off label; however, this is unlikely to have contributed to the reported event.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 doing ok.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: b5: describe event or problem has been updated.H6: medical device probem codes: remove code 4065.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm on (b)(6) 2016 with implant of an afx bifurcated stent graft and an afx vela infrarenal.On (b)(6) 2025 the patient presented emergently in pain.A computed tomography (ct) scan was taken and a type iiib endoleak in the afx vela infrarenal was observed.The physician elected to reline with a new afx vela suprarenal.The endoleak was resolved and the patient¿s final status was reported as okay.

• 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: 23790594
• Report Number: 3011063223-2025-00192
• Device Sequence Number: 10471055
• Product Code: MIH
• UDI-Device Identifier: 00818009013507
• UDI-Public: (01)00818009013507(17)181106
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/14/2025

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 Expiration Date: 11/06/2018
• Device Model Number: A25-25/C95 V
• Device Lot Number: 1408330010
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 01/06/2026; Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/18/2025; 02/06/2026; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 BIFURCATED STENT GRAFT, LOT # UNKNOWN; AFX2 BIFURCATED STENT GRAFT, LOT #1356220022
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female