MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I16-40

Device Problems Material Puncture/Hole (1504); Unintended Movement (3026)

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

Event Date 12/14/2022

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 afx with duraply.Devices remain implanted.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of an afx bifurcated stent graft and an afx vela suprarenal.Approximately six (6) years post initial procedure, the patient presented with an expanding aneurysm, limb movement, and an endoleak (indeterminate origin).The patient's current status is stable and the physician plans to do a re-intervention.

Manufacturer Narrative

The reported 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 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 event/incident.A clinical evaluation of the adverse event/incident was completed.An examination of medical records and/or medical imaging received by endologix shows the afx type ib endoleak of the left common iliac artery, as well as the type iiib endoleak of the distal main body with additional endovascular procedures, are confirmed.The aneurysm enlargement and limb movement complaints are unconfirmed.This is moderately consistent with the reported event/incident.No contributing factors could be identified.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 as stable with the resolution of the endoleaks.No additional investigation of this reported 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 events/incidents.Device iteration is afx with duraply.

Event Description

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the implant of an afx bifurcated stent graft and an afx vela suprarenal.Approximately six (6) years post initial procedure, the patient presented with an expanding aneurysm, limb movement, and an endoleak (indeterminate origin).The patient's current status is stable and the physician plans to do a re-intervention.Additional information: following a re-intervention procedure, the attending physician opted to implant an afx2 bifurcated stent graft, an afx vela suprarenal device, and an ovation ix extender in the patient.Subsequent confirmation revealed the presence of an endoleak type ib as well as an endoleak type iiib.Successful resolution of these endoleaks was reported.The patient's final post-operative status was reported as stable.

• Brand Name: AFX
• 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: 16092147
• MDR Text Key: 306586988
• Report Number: 2031527-2023-00003
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009010049
• UDI-Public: (01)00818009010049(17)181223
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/23/2018
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1292995-017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL 1458318003
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male