MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA22-70/I16-30
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Separation Problem (4043)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	06/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated with endovascular aneurysm repair (evar) using the implantation of an afx2 bifurcated stent graft and an afx vela suprarenal on.Routine computed tomography (ct) scan follow-ups were conducted.Approximately six (6) years after the initial procedure, it was reported that the afx2 bifurcated stent graft and the afx vela suprarenal had migrated ventrally, resulting in reduced overlap length and increased aortic angulation.Despite the migration, the proximal and distal anchoring points remained stable.The migration appeared to have led to a type iiia endoleak due to separation between the devices.Open surgical repair was performed using a non-endologix artificial graft.The distally placed afx2 bifurcated stent graft was fully removed, while the proximally placed afx vela suprarenal was partially cut and anastomosed to the artificial vessel (the excised portion was fully removed).The patient recovered and was discharged in good condition.
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it is not available.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Additional Manufacturer Narrative
The reported 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.Endologix was unable to perform an evaluation of the device as per the distributor the explanted device was not collected from the hospital.A clinical evaluation of the adverse event/incident could not be completed.No medical records nor medical imaging relevant to the reported adverse event/incident were provided to endologix by the distributor.Due to the lack of receipt of relevant medical records and/or imaging; event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.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 incidents.Corrections: h6: investigation finding codes - remove code 3233.H6: investigation conclusion codes - remove code 11.

• 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: 22341543
• Report Number: 3011063223-2025-00113
• Device Sequence Number: 18423461
• Product Code: MIH
• UDI-Device Identifier: 00818009015143
• UDI-Public: (01)00818009015143(17)181018
• 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,Followup
• Report Date (Section B): 05/29/2025

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: 10/18/2018
• Device Model Number: BEA22-70/I16-30
• Device Lot Number: 1750685-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2017
• 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# 1763283-007
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male