MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-90/I16-30
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm and left common iliac artery aneurysm on (b)(6) 2019 with implant of an afx2 bifurcated stent graft (bsg) and an afx vela infrarenal.Due to the occlusion of the left iliac artery, an excluder leg (non-endologix) was deployed from the left common iliac artery (lcia) to the external iliac artery.An afx2 bsg was implanted via the right approach followed by placement of an afx vela infrarenal just below the renal arteries.An aneurysm was also noted in in the right common iliac artery (rcia); however, the procedure was concluded as a staged embolization of the rcia was planned but it is unknown whether the embolization was performed.On (b)(6) 2021 a follow up computed tomography (ct) scan revealed a type ib endoleak from the distal right leg and migration of the proximal stent graft.Consequently, a secondary endovascular aneurysm repair (evar) was performed using an excluder aortic extension (non-endologix) and an excluder leg (non-endologix), along with embolization of the right internal iliac artery.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.
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 iliac artery, implant migration of the proximal extension, and additional endovascular procedure complaints are unconfirmed.This is not consistent with the reported adverse event/incident.Additionally, a non-endologix stent was implanted in the left common iliac artery at index, representing an off-label use.It was also reported that a right common iliac artery aneurysm was present at index.A staged embolization of the right internal iliac artery was expected; however, it is unknown whether this was subsequently performed.Revision of a previously placed graft was also noted, representing a cautionary product use condition.Device, user, procedure, or anatomy relatedness of this complaint could not be determined.Procedure-related harms for this complaint 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.H3 other text: device remains implanted.

• 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: 24835976
• Report Number: 3011063223-2026-00041
• Device Sequence Number: 10447189
• Product Code: MIH
• UDI-Device Identifier: 00818009015136
• UDI-Public: (01)00818009015136(17)210411
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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 Expiration Date: 04/11/2021
• Device Model Number: BEA22-90/I16-30
• Device Lot Number: 2239996002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• 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 INFRARENAL, LOT # 2234540009; EXCLUDER LEG (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male