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

Model Number BA25-90/I16-30

Device Problems Hole In Material (1293); Leak/Splash (1354); Stretched (1601)

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

Event Date 02/27/2015

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 a bifurcated stent and an infrarenal aortic extension.A routine follow up computed tomography (ct) showed the patient had a type 3b endoleak with the main body dilated to 44mm.It was reported the dilation of the main body stent was observed in a follow up ct from 2015, no secondary intervention was completed.The physician elected to reline the initial implanted devices with an additional bifurcated stent and a suprarenal aortic extension to seal the endoleak.The patient is reported to be doing well post procedure.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the clinical assessment for this event, the most likely cause of the compromised stent graft integrity was found to be device related, due to the use of strata material.Procedure related harms could not be determined due to the lack of medical information surrounding the repair event.The final patient disposition is unknown, however, there have been no additional negative patient sequelae reported.A review of the device quality records shows that the device demonstrated compliance to established procedures and specifications at the time of manufacture.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 july 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%.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7051258
• MDR Text Key: 92715706
• Report Number: 2031527-2017-00624
• 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
• Type of Report: Initial,Followup
• Report Date: 10/25/2017

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: 04/30/2016
• Device Model Number: BA25-90/I16-30
• Device Lot Number: 1053221-013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VELA SUPRARENAL- 1203993-029
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR