MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA25-80/I16-40

Device Problems Collapse (1099); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 09/28/2022

Event Type  Injury  

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.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately two (2) years post initial procedure an indeterminate origin endoleak was identified.The physician elected to reline the original implanted devices with another afx2 bifurcated stent graft to resolve this event.The patient was reported as doing fine post secondary procedure and was discharged.

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 indeterminate endoleak was found to be multiple type 2 endoleaks (lumbars).The additional endovascular procedure is confirmed.This is moderately consistent with the reported adverse event/incident.The clinical evaluation also shows reasonable evidence to suggest buckling of the proximal right common iliac stent and sac growth of 5mm occurred that were not included in the event as reported.These findings were discovered during a review of the ct scan dated 03/02/2021 and the angiogram dated 10/13/2022.The event is most likely anatomy related.It was reported that a "cutdown procedure was performed recently that damaged the right main body limb".It is unclear if this contributed to the reported event.No procedure related harms for this complaint were identified.The final patient status was reported to be doing fine.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.

Event Description

The patient was initially implanted with a bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately two (2) years post initial procedure an indeterminate origin endoleak was identified.The physician elected to reline the original implanted devices with another afx2 bifurcated stent graft to resolve this event.The patient was reported as doing fine post secondary procedure and was discharged.Additional information: an internal clinical assessment determined buckling of the proximal right common iliac stent and sac growth of 5mm occurred that were not included in the event as reported.These findings were discovered during a review of the computed tomography (ct) scan dated 03/02/2021 and the angiogram dated 10/13/2022.

• 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: 15629479
• MDR Text Key: 301978962
• Report Number: 2031527-2022-00252
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014733
• UDI-Public: (01)00818009014733(17)230624
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Model Number: BEA25-80/I16-40
• Device Lot Number: 2365169010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AFX SUPRARENAL AORTIC EXTENSION, LOT # 1818592R004
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male