MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for a ruptured abdominal aortic aneurysm on (b)(6) 2026.A cook thoracic stent graft (non-endologix) was implanted first and then the afx2 bifurcated stent graft (bsg) was implanted.The rupture was treated and seal was obtained with a mild type ia endoleak of the cook thoracic stent graft was present.The type ia endoleak was left untreated as it was expected to resolve once off heparin.The discharge computed tomography scan on (b)(6) 2026, found the type ia endoleak from the cook thoracic stent graft and a type ib endoleak from the right limb of the afx2 bsg was observed.The same day reintervention was performed with implant of an ovation ix iliac limb resolving the type ib endoleak.A gore tag graft (non-endologix) was implanted to resolve the type ia endoleak as well as a palmaz stent (non-endologix) to push the aortic cuffs open with better apposition.The patient left the operating room in stable condition.Note: the afx2 system was evaluated using endologix components.The safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.Also, this procedure was off label due to the absence of an abdominal aortic aneurysm.
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 upon completing of clinical evaluation.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.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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 right common iliac artery and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The index procedure was performed in the setting of a ruptured abdominal aortic aneurysm requiring emergent evar.The type ib endoleak, treated six days post-index procedure, is not directly attributable to the rupture itself; however, the emergent nature of the case may have been a contributing procedural factor affecting optimal graft positioning and seal formation, though this could not be conclusively determined.A non-endologix limb extension was used concomitantly in the left common iliac artery at the index procedure; however, this did not contribute to the type ib endoleak involving the right common iliac artery.The type ia endoleak was related to the proximal cook (non-endologix) seal and is not attributed to the endologix system.This off-label product use did not contribute to the type ib endoleak.Device, user, procedure, and anatomy relatedness of the complaint could not be determined.No procedure-related harms were identified.The final patient status was reported as discharge to home on postoperative day one and hospital day seven in stable condition.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: investigation type codes: remove code 4118.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: 24703350
• Report Number: 3011063223-2026-00033
• Device Sequence Number: 10556793
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)280923
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/05/2026

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 Model Number: BEA28-90/I20-30
• Device Lot Number: 2947089006
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2025
• 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: 26MM COOK THORACIC DEVICE (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male