MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-110/I20-30
Medical Device Problem Codes	Off-Label Use (1494); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Stenosis (2263); Clinical Endoleak (4843)
Date of Event	01/06/2026
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.Per communication with jll (distributor) all information for the evaluation of this event that is available has been provided.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.The clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type ia endoleak (resolved with ballooning) is unconfirmed.The stenosis of the contralateral limb is confirmed.The type iiia endoleak is confirmed.The additional endovascular procedure is unconfirmed.This is moderately consistent with the reported adverse event/incident.The stenosis of the left limb is likely user related.The type iiia endoleak is likely anatomy related.No procedure related harms could be determined.The clinical evaluation also shows reasonable evidence to suggest the superior stent margin of the main body was sitting in a 39.7-degree angulation.This likely created decreased apposition and a type iiia endoleak which is anatomy related.It could not be determined if the distal endoleak was a type ii or a type ib endoleak of the left common iliac artery.It was reported at the time of the secondary procedure that no endoleak was visible.The stenosis of the left distal limb was reportedly and likely due to the concomitant product use of an ovation limb.The significant calcifications in the mid to distal left common iliac artery that could have contributed to the reported stenosis and indeterminate endoleak.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.
Event or Problem Description
The patient was implanted with an ovation ix iliac limb, afx2 bifurcated stent graft (bsg), and afx vela suprarenal aortic extension for the treatment of a right internal iliac artery aneurysm (riiaa) and an abdominal aortic aneurysm (aaa) on (b)(6) 2026.The patient was initially treated with coils to embolize the riiaa and percutaneous transluminal angioplasty (pta) was performed in the common internal iliac artery (cia).The physician elected to implant an ovation ix iliac limb in the right iliac artery and a viabahn 8mm-10mm stent graft (non-endologix).The afx2 bifurcated stent graft was inserted via the left side and was deployed in a way that interfered with the proximal portion of the already deployed ovation ix iliac limb.It was reported that during deployment of the contralateral leg, the afx2 leg inverted due to the ovation ix iliac limb, causing stenosis.Although pta was performed, expansion was not sufficient; therefore, the area was relined with a luminexx 12mm-40mm bare metal stent (non-endologix), and pta was performed again.The afx vela infrarenal stent graft was deployed just below the renal arteries.A minor type ia endoleak was observed but resolved after balloon touch-up.The patient was brought back and a ct was performed, there was a possible type iiia endoleak between the afx2 bifurcated stent graft and the afx vela infrarenal extension, and possible type ib endoleak or type ii endoleak in the left iliac leg.On (b)(6) 2026 an angiography was performed and revealed that the possible endoleaks from the ct were not observed, there are no endoleaks.The physician noted that since the post-operative ct was performed a few days after the index procedure, the endoleak might have resolved spontaneously over time.Although no endoleak was recognized on the angiography, two endurant legs (28-82) were overlapped and placed from the proximal to the bifurcation as planned just in case.The procedure was then completed.

• 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: 24394522
• Report Number: 3011063223-2026-00018
• Device Sequence Number: 15934466
• Product Code: MIH
• UDI-Device Identifier: 00818009014542
• UDI-Public: (01)00818009014542(17)280715
• 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: 2026
• 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): 01/27/2026

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: BEA28-110/I20-30
• Device Lot Number: 2926539005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2026
• 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 STENT INFRARENAL GRAFT, LOT# 2888364007; COILS (NON-ENDOLOGIX); LUMINEXX BARE METAL STENT (NON-ENDOLOGIX); OVATION IX ILIAC LIMB: LOT# FS052424-25; VIABAHN STENT GRAFT (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male