MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STANT GRAFT

Model Number	BEA25-80/I20-40
Medical Device Problem Codes	Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft, an afx vela suprarenal, an afx limb stent graft, and an ovation ix extender.Approximately six (6) years post initial procedure, the patient presented with pain and the physician elected to explant the devices.The final patient status is reported as okay.Note: the afx2 system was evaluated using endologix components.The safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.
Additional Manufacturer Narrative
The reported adverse event/incident is being 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 all related devices as well as medical records and medical imaging.Endologix performed an evaluation of the explanted afx2 bifurcated stent graft, afx vela suprarenal extension, and afx limb stent graft for evaluation.The devices were decontaminated.Visual inspection of the afx2 bifurcated stent graft revealed significant tearing in the center section of the stent.A tear was also observed at the proximal end of the afx limb stent graft.A substantial amount of calcification was present within the interior of all three stent-grafts.A detailed examination of the stent graft material (eptfe) indicated no observable degradation of the graft material itself, aside from damage that appeared to have occurred during the explanting process.No inherent defects were identified in the stent graft material.A clinical evaluation of the adverse event/incident has not yet been completed.Patient medical records and imaging studies have been requested for further evaluation; however, these have not yet been received.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
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) afx2 bifurcated stent graft, one (1) afx vela suprarenal extension, and one (1) afx limb stent graft for evaluation.The devices were securely packaged in a box within a biohazard bag.Prior to evaluation, traces of blood and tissue residue were identified, and the devices underwent a decontamination process to eliminate any potential contaminants.Visual inspection of the afx2 bifurcated stent graft revealed significant tearing in the center section of the stent.A tear was also observed at the proximal end of the afx limb stent graft.A substantial amount of calcification was present within the interior of all three stent-grafts.A detailed examination of the stent graft material (eptfe) indicated no observable degradation of the graft material itself, aside from damage that appeared to have occurred during the explanting process.No inherent defects were identified in the stent graft material.Based upon the analysis of the returned device, there is no evidence to suggest a quality problem/deficiency with respect to device manufacturing, design, or labeling.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 was received by endologix.The user facility was unable to provide this information.The initial procedure is off label due to concomitant product usage.The safety and effectiveness of other stent or stent graft devices used in conjunction with the afx2 system have not been established.A 25 mm suprarenal cuff was used in conjunction with a 25 mm main body afx bifurcated stent graft.According to the afx instructions for use (ifu), when selecting a 25mm proximal extension, the diameter should be one size larger than the main body to ensure adequate overlap and sealing.It is unclear if this contributed to the reported event making this cautionary product use.The final patient status is reported as okay.Though a clinical assessment of medical records and medical imaging could not be completed, the report of the device being explanted is confirmed based on return device evaluation.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: h6: investigation type codes ¿ remove code 4117, h6: investigation finding codes ¿ remove code 3233, h6: investigation conclusion codes ¿ remove code 11.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STANT 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
• MDR Report Key: 22035258
• Report Number: 3011063223-2025-00063
• Device Sequence Number: 12965369
• Product Code: MIH
• UDI-Device Identifier: 00818009014689
• UDI-Public: (01)00818009014689(17)200213
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted 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): 04/23/2025

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: 02/13/2020
• Device Model Number: BEA25-80/I20-40
• Device Lot Number: 2080150001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2019
• 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 LIMB STENT GRAFT, LOT#: 1929921006.; AFX VELA SUPRARENAL, LOT#: 2045324001.; OVATION IX EXTENDER, LOT#: FS050516-17.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown