MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-90/I16-30
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/11/2024
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.The reported adverse event/incident was identified by endologix through an ongoing review of industry relevant journal articles.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 devices could not be completed.The devices were not returned to endologix for evaluation because one remains implanted in the patient and the other was discarded after explant by the user facility.A clinical evaluation of the adverse event/incident was completed.An examination of the medical imaging received by endologix found the type iiia endoleak and surgical conversion are confirmed.This is consistent with the reported adverse event/incident.During the investigation, endologix found reasonable evidence to suggest there was severe infrarenal angulation that may have reduced stent overlap and contributed to the reported events; however, causal relationship cannot be conclusively determined based on the information provided.Device, user, procedure or anatomy relatedness of complaint could not be determined.No procedure related harms were identified.The final patient status was reported as discharged home on postoperative day fourteen.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 discarded after explant.
Event or Problem Description
The reported incident was identified by endologix through a retrospective review of an journal article and by the distributor, japan lifeline.Doi: 10.3400/avd.Cr.25-00129 a 76-year-old male was referred for treatment of an infrarenal aaa identified during screening computed tomography (ct).The aneurysm was fusiform, with a maximum diameter of 65 mm and a longitudinal length of 85 mm.The proximal neck measured 37 mm in length with an angulation of 55 degrees.The distal aorta at the aortic bifurcation measured 18 mm in diameter, which prompted the selection of the afx endograft.Although the large aneurysm size raised concerns about secure fixation between the afx2 main body and the vela extension, it was assumed that the presence of extensive mural thrombus would mitigate the risk of migration.Evar was performed using a long afx2 main body (bea25-90-116) and a suprarenal vela extension (a28-28-c95-020v) on 05 january 2022.Intraoperative angiography and postoperative ct revealed no evidence of an endoleak.The required overlap based on the manufacturer's recommendation (aneurysm radius +20mm) was calculated to be 52.5 mm.The overlap was shorter on the outer curvature side than on the inner curvature side.Nevertheless, an overlap length of 57mm was secured, which was considered sufficient at the time.Follow-up consisted of annual ct imaging and plain abdominal radiography.At the 1-year follow-up, the component alignment was generally well maintained; however, plain radiography revealed a slight reduction of several millimeters in the overlap.The aneurysm diameter showed no change compared with the immediate postoperative imaging.Two years post-procedure, imaging demonstrated complete separation between the afx2 main body and the vela extension, resulting in a type iiia endoleak.Given the marked component separation, endovascular reintervention was deemed infeasible, and open surgical repair was undertaken.Under general anesthesia, a midline laparotomy was performed to access the retroperitoneal space.The vela extension reached suprarenally, necessitating a clamp across the mid-portion of the vela itself.Distal control was obtained at both common iliac arteries.Upon opening the aneurysm sac, the complete separation of the components was confirmed.The proximal anastomosis was created by transecting the vela, removing the metallic stents near the cut edge, and then using the remaining graft fabric as a sewing cuff, to which a 16-mm dacron graft was sutured.The distal stent graft components were then completely removed.The postoperative course was uneventful, and the patient was discharged on postoperative day 14.

• 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: 25395170
• Report Number: 3011063223-2026-00062
• Device Sequence Number: 12113730
• Product Code: MIH
• UDI-Device Identifier: 00818009014863
• UDI-Public: (01)00818009014863(17)240715
• 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: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: 07/15/2024
• Device Model Number: BEA25-90/I16-30
• Device Lot Number: 2488962010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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: AXF VELA SUPRARENAL (LOT# 2470133006)
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male