MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C80-O20

Device Problems Unintended Movement (3026); Insufficient Information (3190)

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

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

The device involved in this event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.Device iteration is afx with strata.

Event Description

The patient was initially implanted with an afx bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately eight (8) years post initial implant it was reported the graft has fallen out of the aortic neck and the aneurysm has continued to grow.Re-intervention has been planed and current patient status is doing well.

Event Description

The patient was initially implanted with an afx bifurcated stent graft and a suprarenal aortic extension to treat an abdominal aortic aneurysm (aaa).Approximately eight (8) years post initial implant it was reported the graft has fallen out of the aortic neck and the aneurysm has continued to grow.Re-intervention has been planed and current patient status is doing well.Additional information: a re-intervention was completed on (b)(6) 2020.The physician re-lined the existing stent grafts with an afx2 bifurcated stent graft, a vela suprarenal stent graft, a vela infrarenal stent graft and an ovation ix extender.The type 1a endoleak was resolved and the final patient status was reported to be good following a successful secondary endovascular procedure.

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 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 the sac growth of 27mm complaint is confirmed.The stent migration and type 1a endoleak event/incident were unconfirmed.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 being good following a successful secondary endovascular procedure.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 afx with strata.Corrections: h6: device code: removed code 3026.H6: result code: remove code 3233.H6: conclusion code: remove code 11.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 10863043
• MDR Text Key: 216962320
• Report Number: 2031527-2020-00343
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: A34-34/C80-O20
• Device Lot Number: 1041865-013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT GRAFT 1032427-004; BIFURCATED STENT GRAFT (B)(4)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR