MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number	BA22-90/I16-30
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft (bsg) an excluder cuff (non-endologix) on (b)(6) 2016.In 2023, ankle-brachial index (abi) was 1.0.In 2024, abi was 0.9.In 2025, abi was less than 0.9 and the patient's pulse was palpable but perceived as slightly weak.Contrast ct showed the distal end of the afx (bsg) right leg appeared to be leaning inward.An intervention for percutaneous transluminal angioplasty and additional bare stent placement was being considered.On (b)(6) 2025 the patients was in poor condition due to issues at a site unrelated to this event.The physician elected to not perform the procedure.
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.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 implant movement complaint is unconfirmed.The right common iliac artery stenosis complaint is confirmed.This is moderately consistent with the reported adverse event/incident.A calcified plaque at the inferior margin of the right common iliac artery stent likely contributed to right common iliac artery stenosis.There was concomitant product usage of a non endologix excluder cuff at index making this off label.It is unlikely that this contributed to the reported event.The complaint is likely anatomy related.Procedure related harms could not be determined.The patient¿s final status was reported as poor due to an unrelated event; consequently, the planned secondary procedure was cancelled.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: 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: 23856825
• Report Number: 3011063223-2025-00197
• Device Sequence Number: 4989788
• Product Code: MIH
• UDI-Device Identifier: 00818009010223
• UDI-Public: (01)00818009010223(17)190127
• 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: 2016
• 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): 12/02/2025

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: 01/27/2019
• Device Model Number: BA22-90/I16-30
• Device Lot Number: 1423840014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• 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: EXCLUDER CUFF (NON-ENDOLOGIX)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male