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

Model Number BA28-80/I20-40

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

Patient Problem Failure of Implant (1924)

Event Date 12/04/2017

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 will be submitted.

Event Description

On (b)(6) 2017, endologix was informed about a patient with a main body type 3b endoleak.The patient's physician performed a reline with a gore device (unknown date of procedure).A follow up was made to the patient and the patient is currently doing well.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were not enough evidence to support the following case event of an endoleak type 3b or to confirm the patient's secondary procedure (with a non-endologix device) as it was originally reported.It was noted that the original device is still implanted.A follow up was made to the patient post surgery and the patient is currently doing well and in stable condition.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent graft integrity could not be determined due to lack of information surrounding the initial implant procedure and the secondary endovascular procedure.Procedure related harms and final patient disposition could not be ascertained.Reportedly, the patient was in stable condition after the secondary repair procedure.To date there has 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 iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib 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 iiib 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 iiib endoleak events reported for afx devices has been reduced to less than 0.2%.In addition, the review of manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX, INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7154267
• MDR Text Key: 96035531
• Report Number: 2031527-2017-00706
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

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?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2017
• Device Model Number: BA28-80/I20-40
• Device Lot Number: 1101255-021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/04/2017
• Supplement Dates FDA Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR