MAUDE Adverse Event Report: ENDOLOGIX AFX; INTRODUCER SYSTEM

Model Number	S17-45
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received pending evaluation.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 and/or the device has been received and evaluated, a follow-up report will be submitted.
Event or Problem Description
The patient was being treated for an abdominal aortic aneurysm (aaa) on (b)(6) 2025 with implant of an afx2 bifurcated stent graft and an afx vela suprarenal.Previously a bare (non-endologix) stent had been implanted on the right cia about 20 years ago, and it slightly stuck out to the aortic bifurcation.The afx introducer sheath was inserted through right access, however, it was not able to be advanced because it got caught in the bare (non-endologix) stent.An attempt was made again by replacing the sheath with a dryseal (non-endologix) but it was unsuccessful.The afx introducer sheath was able to be advanced through left access although it got caught in the bare (non-endologix) stent, however the afx2 main body was implanted.Afterwards, when the sheath was removed, the ra marker of the afx introducer sheath was left between the ipsilateral leg and blood vessel.Since it was stuck, the procedure continued.A new afx sheath was used to implant the afx vela suprarenal.After overall touch-up, it was confirmed there were no endoleaks, and the procedure was completed.The current patient status is unknown.
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 returned device was completed.A visual and where possible functional analysis was performed.Endologix received one (1) afx introducer system.The device arrived securely packaged in both a box and protective bagging.Upon initial inspection, traces of blood and tissue residue were observed.As a precaution, the device was decontaminated before sample evaluation.A thorough assessment was conducted, including a visual inspection.The analysis revealed structural damage at the tip of the outer sheath.An incision was made at the sheath tip, confirming the absence of a radiopaque marker.Based on these findings, endologix is able to confirm the reported event of detachment of components.The root cause of the reported issues cannot be conclusively determined.A clinical evaluation of the adverse event/incident was completed.The difficult to advance the introducer system complaint is unconfirmed.The detachment of component (radiopaque marker) complaint is confirmed based on return product analysis.This is moderately consistent with the reported adverse event/incident.It was reported that the afx sheath became stuck on a previously placed bare stent in the right common iliac artery.The clinical evaluation shows reasonable evidence to suggest this likely contributed to the reported event but could not conclusively be determined.During the investigation, endologix found reasonable evidence to suggest the device was used off-label due to the patient anatomy since the left common iliac artery distal diameter was 7.8mm and should be 10-20mm.Device, user, procedure or anatomy relatedness of this complaint cannot be determined.Procedure related harms could not be determined.The final patient status was not provided.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 ¿ updated.H6: investigation finding codes ¿ remove code 3233.H6: investigation conclusion codes ¿ remove code 11.

• Brand Name: AFX
• Common Device Name: INTRODUCER SYSTEM
• 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: 22143142
• Report Number: 3011063223-2025-00101
• Device Sequence Number: 7276017
• Product Code: MIH
• UDI-Device Identifier: 00818009011381
• UDI-Public: (01)00818009011381(17)270702
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S17-45
• Device Lot Number: 2828412006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/24/2024
• 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# 2680782009); AFX2 BIFURCATED STENT GRAFT (LOT# 2815907001)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Unknown