MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-60/I13-40
Medical Device Problem Codes	Off-Label Use (1494); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with an afx2 bifurcated stent graft, an afx vela suprarenal extension, and two ovation iliac limbs for the treatment of thrombosis on (b)(6) 2021.This initial procedure is outside the indications of use (off-label) since there is no abdominal aortic aneurysm present.It was reported that the patient presented emergently with pain on (b)(6) 2025.The computed tomography (ct) revealed that there is thrombosis in aorta extending bilaterally distally through the iliac limbs.The physician elected to reline the entire stent graft system, with an afx2 bifurcated stent graft and two (2) ovation iliac limbs.The intervention was successful.The patient is doing well.
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.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.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 occlusion is unconfirmed.The additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be identified.The clinical evaluation also shows reasonable evidence to suggest the initial procedure falls outside the approved indications for use and is considered off-label.It was reported that at the time of the index procedure, the patient was being treated for thrombosis, and no abdominal aortic aneurysm was present.This may have contributed to the reported events; however, definitive causation could not be conclusively determined.There was concomitant product usage of ovation limb extensions at the time of the index procedure.It is unclear if this contributed to the reported event.The additional endovascular procedure is confirmed.The final patient status was reported as doing well.No additional investigation of this reported adverse event/incident is planned.Endologix will continue to monitor this and similar adverse events/incidents.Device iteration is afx2.Corrections: g3: awareness date has been updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix practice to make at least three good faith efforts to retrieve a reported adverse event/incident related device as well as medical records and medical imaging.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 occlusion is unconfirmed.The additional endovascular procedure complaint is confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of complaint could not be determined.Procedure related harms could not be identified.The clinical evaluation also shows reasonable evidence to suggest the initial procedure falls outside the approved indications for use and is considered off-label.It was reported that at the time of the index procedure, the patient was being treated for thrombosis, and a rupture due to a mycotic abdominal aortic aneurysm.This may have contributed to the reported events; however, definitive causation could not be conclusively determined.There was concomitant product usage of ovation limb extensions at the time of the index procedure.It is unclear if this contributed to the reported event.The additional endovascular procedure is confirmed.The final patient status was reported as doing well.No additional investigation of this reported adverse event/incident is planned.Endologix will continue to monitor this and similar adverse events/incidents.Corrections: b5: describe event or problem has been updated.B6: relevant tests and lab data has been updated.G3: awareness date has been updated.
Event or Problem Description
The patient was implanted with an afx2 bifurcated stent graft, an afx vela suprarenal extension, and two ovation iliac limbs for the treatment of thrombosis on (b)(6) 2021.This initial procedure is outside the indications of use (off-label) since there is no abdominal aortic aneurysm present.It was reported that the patient presented emergently with pain on (b)(6) 2025.The computed tomography (ct) revealed that there is thrombosis in aorta extending bilaterally distally through the iliac limbs.The physician elected to reline the entire stent graft system, with an afx2 bifurcated stent graft and two (2) ovation iliac limbs.The intervention was successful.The patient is doing well.Additional information was received for this case.The patient was implanted with an afx2 bifurcated stent graft, an afx vela suprarenal extension, and two ovation iliac limbs for the treatment of a ruptured mycotic abdominal aortic aneurysm and thrombosis on (b)(6) 2021.This case is outside the indications of use (off -label) due to pre-existing infection.

• 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: 21339602
• Report Number: 3011063223-2025-00015
• Device Sequence Number: 3772472
• Product Code: MIH
• UDI-Device Identifier: 00818009015068
• UDI-Public: (01)00818009015068(17)231013
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2025

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: 10/13/2023
• Device Model Number: BEA22-60/I13-40
• Device Lot Number: 2394151005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 03/25/2025; 05/22/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 04/17/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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 SUPRARENAL: LOT # 2327560010.; OVATION IX ILIAC LIMB: LOT # FS032321-52.; OVATION IX ILIAC LIMB: LOT # FS062220-19.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male