MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-100/I20-40

Device Problems Collapse (1099); Material Puncture/Hole (1504)

Patient Problem Aneurysm (1708)

Event Date 04/11/2023

Event Type  Injury  

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.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of the afx2 bifurcated stent graft and an afx vela suprarenal on (b)(6) 2016.The routine follow-up performed on (b)(6) 2023, identified a possible type iiia endoleak or a possible type iiib endoleak.Reintervention was completed with the implant of an alto abdominal stent graft system on (b)(6) 2023.It was determined that the endoleak was a type iiib.The final outcome was successful.

Manufacturer Narrative

The reported 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 that the type iiib endoleak of the afx2 bifurcated stent graft and additional endovascular procedure complaints are confirmed.This is consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest aneurysm enlargement of 17mm and buckling of the left iliac stent occurred that was not included in the reported event as reported.The aneurysm enlargement and buckling were discovered during review of the computed tomography scan report dated (b)(6) 2023.Procedure related harms, device, user, procedure or anatomy relatedness of this complaint could not be determined with the medical records available for review.The final patient status was reported to be discharged to home in better condition.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.G3: awareness date ¿ updated h6: investigation finding codes - remove code 3233 h6: investigation conclusion codes - remove code 11.

Event Description

The patient was treated for an abdominal aortic aneurysm (aaa) with the implant of the afx2 bifurcated stent graft and an afx vela suprarenal on (b)(6) 2016.The routine follow-up performed on (b)(6) 2023, identified a possible type iiia endoleak or a possible type iiib endoleak.Reintervention was completed with the implant of an alto abdominal stent graft system on (b)(6) 2023.It was determined that the endoleak was a type iiib.The final outcome was successful.After the initial report, the clinical evaluation also shows reasonable evidence to suggest aneurysm enlargement of 17mm and buckling of the left iliac stent occurred that was not included in the reported event as reported.The aneurysm enlargement and buckling were discovered during review of the computed tomography scan report dated (b)(6) 2023.

• Brand Name: AFX2
• Type of Device: 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: 16865617
• MDR Text Key: 314524337
• Report Number: 2031527-2023-00148
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014672
• UDI-Public: (01)00818009014672(17)170205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2017
• Device Model Number: BEA25-100/I20-40
• Device Lot Number: 1355345002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0007-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL (LN 1469344010)
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male