MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; VELA INFRARENAL

Model Number A34-34/C100V

Device Problems Material Puncture/Hole (1504); Stretched (1601); Material Integrity Problem (2978); Unintended Movement (3026)

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

Event Date 11/06/2018

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

An afx bifurcated stent graft, and an afx vela inrarenal were implanted to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post initial procedure, a type 1a and 3b endoleak with aaa expansion was identified during a follow-up ct.Additionally, the 34 mm aortic extension measured at 46 mm, indicating that the vela material is no longer intact or has torn with stent expansion out to max diameter of 46 mm.Re-intervention was completed with implant of two (2) non-endologix grafts, an afx2 bifurcated stent graft, and an afx vela infrarenal.Due to difficulty during the procedure, the physician had to convert into aui graft with blood flow to right side only and fem to fem bypass.

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported events of a type 1a endoleak with sac growth and intervention.The reported 3b endoleak was refuted, rather there was stent cage dilation with no leak present.Additional findings of a non - endologix was placed in the left common iliac artery at the initial implant and movement between the infrarenal proximal extension and the bifurcated stent graft with no leak present.The cause of the type 1a endoleak is mostly likely anatomy related due to the aortic remodeling and the stent cage dilation is mostly likely anatomy related due to intramural thrombus.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX
• Type of Device: VELA INFRARENAL
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 8295191
• MDR Text Key: 134702160
• Report Number: 2031527-2019-00070
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009014559
• UDI-Public: (01)00818009014559(17)170314
• 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: Recall
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2015
• Device Model Number: A34-34/C100V
• Device Lot Number: 1178434025
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1049-2017
• Patient Sequence Number: 1
• Treatment: AFX BIFURCATED STENT GRAFT (LN 1101199-004)
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR