MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-80/I20-40

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

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

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

Endologix will continue to investigate the reported event.The patient medical records and imaging studies have been requested for further evaluation by a clinical specialist.A final report will be submitted once the investigation of the reported event has concluded.

Event Description

An afx bifurcated stent graft and an afx vela suprarenal were implanted to treat an abdominal aortic aneurysm (aaa).Approximately five (5) years post op, a routine follow-up ct identified aneurysm sac growth (unknown diameter), with less than two cms of overlap, both native iliacs were dilated with a possible type ib endoleak.Re-intervention was successfully completed with an ovation ix abdominal stent graft system full re-line as the index device was strata.The patient is well.

Manufacturer Narrative

A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and or imaging; requests were made and no response was received for medical imaging and denied for medical records.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.The manufacturing lot review confirmed all devices met specifications prior to release.These types of events will be monitored and trended as part of the quality system.Device iteration is afx with strata.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8545379
• MDR Text Key: 142941892
• Report Number: 2031527-2019-00209
• 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
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: BA28-80/I20-40
• Device Lot Number: 1101255-053
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 03/26/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL (LN 1230481026); AFX VELA SUPRARENAL (LN 1230481026)
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR