MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-90/I20-30
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this event will not be returned for evaluation as it remains implanted in the patient.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, a follow-up report will be submitted.Device iteration is afx2.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent, two (2) endurant cuffs (non-endologix device), and one (1) excluder cuff (non-endologix device).Approximately four (4) years post initial procedure, an angiography identified a type 3b endoleak.Reintervention was completed with the implant of an afx2 bifurcated stent graft.It was reported that the 3b endoleak was resolved after the secondary procedure.The final patient status remains unknown.The final patient status was not made available to endologix.This event was previously reported under (mfr # 2031527-2021-00501).Now, approximately one and half (1.5) years later during a routine follow up, a type 1b was identified and it was originating from the recently implanted afx2 bifurcated stent graft via the right common iliac artery (cia).It was also noted that sac enlargement was not observed, and the patient is currently asymptomatic.The patient is currently being monitored while an intervention is being discussed.Note: the initial procedure performed on (b)(6) 2017, was off label due to the concomitant use with products outside the (ifu) instructions for use.
Additional Manufacturer Narrative
The reported adverse event/incident was 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 a reported adverse event/incident related device as well as medical records and medical imaging.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.The review confirms there were no manufacturing or processing non-conformities identified that would contribute to the reported adverse event/incident.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 type 1b endoleak of the right common iliac artery and additional endovascular procedure are unconfirmed.This is not consistent with the reported adverse event/incident.As reported, there was concomitant product usage of a non endologix stent in the distal area of the right common iliac artery.This could have contributed to the reported events however could not be conclusively determined due to lack of imaging for review.Device, user, procedure or anatomy relatedness of this complaint could not be determined.Procedure related harms for this complaint could not be determined.The final patient status was not reported.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: h6: health effect - impact code: remove code 4614.H6: investigation finding codes: remove code 3233.H6: investigation conclusion codes: remove code 11.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with an afx2 bifurcated stent, two (2) endurant cuffs (non-endologix device), and one (1) excluder cuff (non-endologix device).Approximately four (4) years post initial procedure, an angiography identified a type 3b endoleak.Reintervention was completed with the implant of an afx2 bifurcated stent graft.It was reported that the 3b endoleak was resolved after the secondary procedure.The final patient status remains unknown.The final patient status was not made available to endologix.This event was previously reported under (mfr # 2031527-2021-00501).Now, approximately one and half (1.5) years later during a routine follow up, a type 1b was identified and it was originating from the recently implanted afx2 bifurcated stent graft via the right common iliac artery (cia).It was also noted that sac enlargement was not observed, and the patient is currently asymptomatic.The patient is currently being monitored while an intervention is being discussed.Note: the initial procedure performed on (b)(6) 2017, was off label due to the concomitant use with products outside the (ifu) instructions for use.Additional information: an endurant (non-endologix) limb was implanted (b)(6) 2023 on each side and the type 1b endoleak was resolved.The final patient status was not reported to endologix.

• 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: 17199930
• Report Number: 2031527-2023-00173
• Device Sequence Number: 6667119
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)231021
• 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: 2021
• 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): 06/06/2023

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: 10/21/2023
• Device Model Number: BEA28-90/I20-30
• Device Lot Number: 2396272003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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: AFX2 BIFURCATED STENT GRAFT, LOT # 1685409-002; MEDTRONIC ENDURANT (NON-ENDOLOGIX) CUFF; MEDTRONIC ENDURANT (NON-ENDOLOGIX) CUFF
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 75 YR
• Patient Sex: Male