MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA25-90/I20-30
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Thrombosis/Thrombus (4440); Clinical Endoleak (4843)
Date of Event	02/26/2025
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.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 aneurysm enlargement of 19.5mm, an indeterminate endoleak and additional endovascular procedure are confirmed.This is moderately consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of the complaint could be determined.No procedure related harms were identified.The clinical evaluation also shows reasonable evidence to suggest the increased angulation and a decreased overlap from 49mm to 23mm are likely related to aortic remodeling.The decrease in overlap between the proximal cuff and the main body of the stent graft may have contributed to the development of a type iiia endoleak.However, this could not be conclusively determined due to thrombus.The presence of intrastent thrombus made it difficult to conclusively determine what type of endoleak was present.The patient was reportedly lost to follow up is cautionary use.The final patient status was reported as discharged home on postoperative day one 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: awareness date has been updated.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.
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 afx with duraply.
Event or Problem Description
The patient was initially implanted with an afx bifurcated stent graft (bsg) and an afx vela suprarenal aortic extension for the treatment of an abdominal aortic aneurysm (aaa) on (b)(6) 2015.It was reported during a recent routine follow-up, the angiogram revealed aneurysm enlargement.The angiogram on (b)(6) 2025 demonstrated that there is a minimal overlap between the afx bsg and afx vela suprarenal aortic extension.Due to thrombosis there is no apparent endoleak visible, however there is aaa enlargement most likely due to an indeterminate endoleak.The physician elected to reline the entire endograft system with the implantation of an afx2 bsg and an afx vela suprarenal aortic extension.The case was completed, there was complete inclusion of the previously implant stent grafts.The patient was stable post intervention and was discharged home one day post intervention.

• Brand Name: AFX
• 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: 21643287
• Report Number: 3011063223-2025-00030
• Device Sequence Number: 20772338
• Product Code: MIH
• UDI-Device Identifier: 00818009012227
• UDI-Public: (01)00818009012227(17)180512
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 02/26/2025

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: 05/12/2018
• Device Model Number: BA25-90/I20-30
• Device Lot Number: 1341379007
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2015
• 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# 1252433007
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male