MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I20-40
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
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 afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx limb stent graft distal extension.Approximately one (1) year post initial procedure, the patient presented with a type ib endoleak from the left common iliac.The physician elected to treat the patient by extending the left external iliac with one (1) additional afx limb stent graft on (b)(6) 2023.The endoleak was successfully resolved and the patient has been discharged.
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 the reported afx2 type ib endoleak (of the left common iliac artery) and additional endovascular procedure are confirmed.This is consistent with the reported adverse event/incident.No procedure-related harms were identified.Device, user, procedure, or anatomy relatedness of this event could not be determined with the medical records available for review.It was also noted that the aortic neck diameter was off-label and there was concomitant product use of non-endologix stents at the initial implant procedure; however, these factors did not appear to contribute to the type ib endoleak.In addition, patient had a thoraco-abdominal aneurysm at initial implant (cautionary product use condition).The final patient status was reported as discharged.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 afx with duraply.
Event or Problem Description
The patient was initially treated for an abdominal aortic aneurysm (aaa) with implant of an afx2 bifurcated stent graft and an afx limb stent graft distal extension.Approximately one (1) year post initial procedure, the patient presented with a type ib endoleak from the left common iliac.The physician elected to treat the patient by extending the left external iliac with one (1) additional afx limb stent graft on 23 february 2023.The endoleak was successfully resolved and the patient has been discharged.Additional information: clinical assessment identified that two (2) gore (non-endologix) proximal/thoracic stents were also implanted at the initial case on (b)(6)2022; this procedure is outside the indications of use (off-label) due to adjunctive devices not compatible with the afx2 system per device ifu.In addition, the patient had a thoraco-abdominal aneurysm.

• 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: 16499462
• Report Number: 2031527-2023-00039
• Device Sequence Number: 15087180
• Product Code: MIH
• UDI-Device Identifier: 00818009014399
• UDI-Public: (01)00818009014399(241109
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/16/2023

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: 11/09/2024
• Device Model Number: BEA28-120/I20-40
• Device Lot Number: 2523250-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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, SN 2329661-003; AFX LIMB STENT GRAFT, SN 2329661-003; GORE (NON-ENDOLOGIX) THORACIC STENT #1; GORE (NON-ENDOLOGIX) THORACIC STENT #2
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male