MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA25-70/I16-30
Medical Device Problem Codes	Off-Label Use (1494); Lack of Effect (4065)
Health Effect - Clinical Codes	Ruptured Aneurysm (4436); Clinical Endoleak (4843)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was treated for an emergency endovascular aneurysm repair (evar) on (b)(6) 2023.Several gore (non-endologix) viabahn vbx balloon expandable endoprosthesis (vbx stent graft) had previously been implanted in the right common iliac artery (cia) to the external iliac artery (eia).During this evar, an afx2 bifurcated stent graft was implanted from the left access and an additional vbx stent graft was also added.(this initial procedure is outside of the indications of use (off-label) due to the use of adjunctive devices not compatible with the afx2 system).On (b)(6) 2023 an emergency evar was performed due to aneurysm rupture.Reportedly, it was possibly due to type iiia endoleak due to the vbx stent graft migration or a type iiib endoleak of the afx2 bifurcated stent graft; however, this was not definitively determined.A medtronic (non-endologix) endurant cuff was added at the proximal portion, and a vbx stent graft was added from the right cia to eia.An afx introducer sheath was inserted and an afx2 bifurcated stent graft delivery system was docked.Small resistance was felt when docking devices, but the sheath valve was confirmed in open position.The physician attempted to advance the afx2 delivery system, but a strong resistance was felt, and the physician was unable to advance the afx2 delivery system any further.The physician was also unable to remove the afx2 delivery system from the afx introducer sheath; therefore, both were removed from the body together.When removed, significant afx introducer sheath tip damaged was identified.The procedure was completed with a new afx introducer sheath and the successful implant of a new afx2 bifurcated stent graft.The final patient status was not reported.
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.An evaluation of the device could not be completed.The device was not returned to endologix for evaluation because the device 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 rupture (iliac); possible type iiia or type iiib endoleak; reintervention complaints are unconfirmed.This is not consistent with the reported adverse event/incident.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms for this complaint were identified.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.

• 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: 18136826
• Report Number: 3011063223-2023-00031
• Device Sequence Number: 17782127
• Product Code: MIH
• UDI-Device Identifier: 00818009014870
• UDI-Public: (01)00818009014870(17)240907
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2023

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: 09/07/2024
• Device Model Number: BEA25-70/I16-30
• Device Lot Number: 2504911016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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: GORE (NON-ENDOLOGIX) VBX BES ENDOPROSTHESIS.; GORE (NON-ENDOLOGIX) VBX BES ENDOPROSTHESIS.; GORE (NON-ENDOLOGIX) VBX BES ENDOPROSTHESIS.; GORE (NON-ENDOLOGIX) VBX BES ENDOPROSTHESIS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male