MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-80/I20-40
Medical Device Problem Codes	Material Puncture/Hole (1504); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially implanted with an afx2 bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa) and a right common iliac artery aneurysm.Prior to implant of the endologix afx2 bifurcated stent graft and the suprarenal aortic extension, the right internal iliac artery was first occluded with non-endologix (azur coils), followed by a non-endologix (16x12x10 excluder leg) which was implanted in the proximal right common iliac artery.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with afx system per the ifu.An angiogram was performed and showed a type 1a endoleak (with anterograde flow to the lumbar artery).Balloon touch-up was performed at several points, and angiography was performed again.The type 1a endoleak was resolved.However, an endoleak was observed around the proximal end of the right common iliac artery.Another angiogram was performed, and a type 1b endoleak was excluded.An additional angiogram was performed from within the stent graft and identified a possible type 3b endoleak.The physician elected to implant another afx2 bifurcated stent graft and the endoleak volume decreased but did not completely resolve.The physician determined the endoleak will resolve spontaneously.No further intervention was performed and the patient will be monitored.
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.Device remains implanted.
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 3b endoleak is unconfirmed.This is not consistent with the reported adverse event/incident.The concomitant product use of non endologix excluder limbs is off label.The aneurysm sac was 43.8mm (should be >50mm).It appears the superior stent margin of the non endologix stent placed in the right common iliac artery was near the endoleak.It could not be determined if this contributed to the reported event.It could not be conclusively determined the endoleak was a type 3b endoleak with the provided imaging.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 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.Corrections: g3: awareness date has been updated.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: 16865474
• Report Number: 2031527-2023-00143
• Device Sequence Number: 5957795
• Product Code: MIH
• UDI-Device Identifier: 00818009014689
• UDI-Public: (01)00818009014689(17)250816
• 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: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2023

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: 08/16/2025
• Device Model Number: BEA25-80/I20-40
• Device Lot Number: 2604158007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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: AZUR COILS (NON-ENDOLOGIX); BIFURCATED STENT GRAFT, LOT # 2614275005; EXCLUDER LEG (NON-ENDOLOGIX); SUPRARENAL AORTIC EXTENSION, LOT # 2614898011
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male