MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number BEA28-110/I20-30

Device Problem Unintended Movement (3026)

Event Date 01/17/2023

Event Type  Injury  

Event Description

The patient was initially implanted with an afx2 bifurcated stent graft and an infrarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post initial procedure, during a routine follow up, the graft appears pushed proximally and is no longer on anatomical bifurcation.Additionally, a type 1b endoleak is identified.The patient is currently stable and is being monitored while an intervention is being discussed.

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.Device remains implanted.

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 implant movement and type 1b endoleak are unconfirmed.This is not consistent with the reported adverse event/incident.Additionally, the clinical assessment noted that when selecting a 22, 25, or 28mm proximal extension, a diameter one size larger than the main body of the bifurcated stent graft is recommended.It is unclear if this contributed to the reported event.Device, user, procedure or anatomy relatedness of this complaint could not be determined.No procedure related harms were identified.The final patient status was reported to be discharged home on postoperative day three.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
• 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: 16308962
• MDR Text Key: 308914320
• Report Number: 2031527-2023-00020
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014542
• UDI-Public: (01)00818009014542(17)180825
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2018
• Device Model Number: BEA28-110/I20-30
• Device Lot Number: 1732336012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2017
• 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 INFRARENAL AORTIC EXTENSION, LOT # 1675558014
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male