MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number BA28-80/I16-40

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Hole In Material (1293); Leak/Splash (1354)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

The patient was initially implanted with afx devices in 2014.In 2016 it was reported there was an issue detected with the device.At 49 weeks after the detection of the device issue the patient presented with abdominal pain and the physician scheduled a secondary intervention.The completion of a secondary intervention has not been reported.The current patient status is unknown.There have been no additional adverse events reported for this patient.

Event Description

It was reported that a conversion procedure was performed on (b)(6) 2017.Pictures of the explant have been provided.Patient condition post-conversion is stable.

Manufacturer Narrative

A review of the manufacturing lot confirmed all devices met specifications prior to release.The explanted devices will not be returned and no evaluation will be completed.Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.Clinical was able to confirm the surgical conversion performed on (b)(6) 2017 and in addition, noted that the main body stent had a dilation of the superior stent margin of the bifurcated stent (28%) with a type 3b endoleak at the bifurcation with stent buckling.It was also confirmed that there was also stent buckling (95%) and a type 3b on the upper most suprarenal cuff, and on the lower suprarenal: crown separation; a type 3b endoleak with 169% dilation, multiple stent fractures of the cage; and a type 3a endoleak with complete implant separation (both events will be reported in 2 separate reports; reference 2031527-2018-00234 and 2031527-2018-00235).The most likely cause of the compromised stent graft integrity of both cuffs and the main body stent was the use of strata material.The most likely cause of the multiple stent fractures and crown separation of the lower cuff could not be identified due to lack of medical imaging surrounding the event.However the complete component separation and severe buckling of the upper most cuff and main body stent was likely a result of an elongated rendering of treatment, reportedly, 1.5 to 2.0 years from the onset of a non descriptive device issue.Reportedly, the patient was doing well post explant; there have been no reports of further negative patient sequelae.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b endoleak events; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place (b)(6) 2014.The type 3b endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type 3b endoleak events reported for afx devices has been reduced to less than 0.2%.These types of events will be monitored and trended as part of the quality system.(b)(4),.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7179228
• MDR Text Key: 96870074
• Report Number: 2031527-2018-00026
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

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: 02/28/2017
• Device Model Number: BA28-80/I16-40
• Device Catalogue Number: F00426
• Device Lot Number: 1055382-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 04/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUPRARENAL AORTIC EXTENSION, LOT 1050593-059; SUPRARENAL AORTIC EXTENSION, LOT 1054874-025
• Patient Outcome(s): Other