MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-70/I16-30
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal stent graft for the treatment of an abdominal aortic aneurysm (aaa) on (b)(6) 2019.Approximately five years after the initial procedure, during a follow-up on (b)(6) 2024, it was discovered that the junction between the main body and the vela had separated.The aneurysm had not enlarged due to the presence of a mural thrombus.The treatment plan for this issue is currently under discussion.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's practice to make at least three good-faith efforts to retrieve a reported adverse event/incident-related device as well as the associated medical records and imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination required for device identification shows that the device was properly manufactured and released in accordance with the device master record.This review confirms that there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.The device was not returned to endologix for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix confirms the presence of a type iiia endoleak with complete component separation.This is consistent with the reported adverse event/incident.Endologix was unable to identify the contributing factors due to a lack of comparative medical information.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.The patient's final status was reported as being monitored.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.Device iteration is afx2.
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and an afx vela suprarenal stent graft for the treatment of an abdominal aortic aneurysm (aaa) on (b)(6)2019.Approximately five years after the initial procedure, during a follow-up on (b)(6) 2024, it was discovered that the junction between the main body and the vela had separated.The aneurysm had not enlarged due to the presence of a mural thrombus.The treatment plan for this issue is currently under discussion.Additional information.On (b)(6) 2024, the patient underwent a re-intervention during which the physician elected to implant an afx vela suprarenal.A touch-up procedure was performed prior to re-angiography.The procedure was completed after confirming the absence of any endoleak.Post-procedure, the patient¿s blood pressure was within normal limits, and their condition was stable, with no evidence of vascular damage.
Additional Manufacturer Narrative
The reported adverse event/incident was investigated in alignment with endologix operating procedures and work instructions.Where possible, it is endologix's practice to make at least three good-faith efforts to retrieve a reported adverse event/incident-related device as well as the associated medical records and imaging.An evaluation of the manufacturing record was completed.A review of the part number/lot number combination required for device identification shows that the device was properly manufactured and released in accordance with the device master record.This review confirms that there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.The device was not returned to endologix for evaluation.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the type iiia endoleak with complete component separation is confirmed.The additional endovascular procedure is unconfirmed.This is moderately consistent with the reported adverse event/incident.Procedure-related harms, device, user, procedure, or anatomy-relatedness of this complaint could not be determined with the medical records available for review.Clinical assessment was unable to identify the contributing factors due to a lack of comparison of medical information.The final patient status was reported as being stable, with no evidence of vascular damage.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.Device iteration is afx2 corrections: b2: outcomes attributed to adverse events has been updated b5: describe event or problem has been updated g3: date received by manufacturer has been updated.H6: health effect - impact code: remove code 4614 h10/11: addtl mfg narrative has been updated.

• 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
• MDR Report Key: 20608861
• Report Number: 3011063223-2024-00156
• Device Sequence Number: 20810743
• Product Code: MIH
• UDI-Device Identifier: 00818009014603
• UDI-Public: (01)00818009014603(17)200517
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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: 05/17/2020
• Device Model Number: BEA28-70/I16-30
• Device Lot Number: 2249098-004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0007-2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AFX VELA SUPRARENAL (LN 2004255-005)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male