MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-100/I16-40
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implantation of an afx2 bifurcated stent graft, an afx vela suprarenal, and an ovation ix extender.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx system, as per the instructions for use (ifu).Approximately four and a half (4.5) years after the initial procedure, a follow-up computed tomography angiography (cta) revealed an aneurysm enlargement and the presence of an endoleak type ib.In response to these findings, the patient underwent a re-intervention, during which the attending physician implanted an ovation ix extender as well as an afx limb stent graft.The final patient status remains unknown.The final patient status was not made available to endologix.
Additional Manufacturer Narrative
The devices involved in this event will not be returned for evaluation and remain implanted in the patient.Patient medical records and imaging studies will be requested for further evaluation by a clinical specialist.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx2.H3 other text : 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's 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.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 the type ib endoleak with sac growth of 5mm (left iliac artery), and the additional endovascular is confirmed.This is consistent with the reported adverse event/incident.The complaint is most likely user-related.The diameter of the left common iliac artery measured 31mm at the index, a dimension outside the recommended range of 10-23mm, thus falling into the off-label category.Additionally, the concomitant use of an ovation extension in the left iliac at the index is also considered off-label.Procedure-related harms of this complaint could not be determined with the medical records available for review.The final patient status was reported as being recovered and discharged on the first post-operative day.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: b5: describe event or problem g3: awareness date has been updated 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 the implantation of an afx2 bifurcated stent graft, an afx vela suprarenal, and an ovation ix extender.This initial procedure is outside the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx system, as per the instructions for use (ifu).Approximately four and a half (4.5) years after the initial procedure, a follow-up computed tomography angiography (cta) revealed an aneurysm enlargement and the presence of an endoleak type ib.In response to these findings, the patient underwent a re-intervention, during which the attending physician implanted an ovation ix extender as well as an afx limb stent graft.The final patient status remains unknown.The final patient status was not made available to endologix.Additional information: the final patient status was reported as being recovered and discharged on the first post operative day.

• 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: 18177757
• Report Number: 3011063223-2023-00037
• Device Sequence Number: 7568123
• Product Code: MIH
• UDI-Device Identifier: 00818009014450
• UDI-Public: (01)00818009014450(17)200208
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2023

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: 02/08/2020
• Device Model Number: BEA28-100/I16-40
• Device Lot Number: 2062808001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2019
• 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 VELA SUPRARENAL 1784916007; OVATION IX EXTENDER FS050418-41
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male