MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I16-30
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	02/04/2025
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.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa).Angioplasty with bare metal stents (non-endologix) was performed in both iliac arteries due to significant calcification in the left common iliac artery (lcia) and luminal narrowing in the right common iliac artery (rcia).The physician then implanted an afx2 bifurcated stent graft and an afx vela suprarenal proximal extension.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.Final angiography confirmed the absence of an endoleak and the procedure was completed.Approximately two (2) years post initial procedure, during a routine follow-up, aneurysm enlargement was observed.A month later a contrast-enhanced computed tomography (cect) scan was performed to investigate the aneurysm enlargement.The imaging raised suspicion for a type iii or type ii endoleak.Angiography was also performed but failed to identify the specific type of the endoleak.The final patient status is unknown.
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 aneurysm enlargement complaint is unconfirmed.The endoleak of indeterminate origin complaint, determined to be a type iiia endoleak (poor apposition) of the main body, proximal cuff and type ii endoleak of the lumbar arteries is confirmed.This is moderately consistent with the reported adverse event/incident.The superior stent margin of the main body was sitting in area of angulation likely causing poor apposition of the main body to the proximal cuff.This likely contributed to the type iiia endoleak.The type ii endoleak of the lumbar arteries is anatomy related.There was concomitant product usage (bare metal stents in both iliac arteries) of non endologix stents making this off label.It is unlikely this contributed to the reported event.The clinical assessment determined that there was evidence to reasonably suggest additional endovascular procedure (diagnostic angiogram) occurred that was not included in the event as reported.The additional endovascular procedure complaint was discovered during review of the short video's post implant.The type iiia endoleak was determined to be anatomy related.The type ii endoleak complaint is anatomy related.Procedure related harms could not be determined.The final patient status was not reported.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: g3: date received by manufacturer has been updated.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• 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: 21858913
• Report Number: 3011063223-2025-00044
• Device Sequence Number: 17317437
• Product Code: MIH
• UDI-Device Identifier: 00818009014863
• UDI-Public: (01)00818009014863(17)250902
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2025

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: 09/02/2025
• Device Model Number: BEA25-90/I16-30
• Device Lot Number: 2608318007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/30/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL, LOT # 2575834005.; BARE METAL STENT(NON-ENDOLOGIX).; BARE METAL STENT(NON-ENDOLOGIX).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male