MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C80-O20

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907); Material Integrity Problem (2978); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 09/15/2018

Event Type  Injury  

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.Clinical had substantial evidence to support the following additional findings of implant separation, stent migration and stent cage dilation (3b endoleak) of the suprarenal stent graft extension (cuff) that was implanted on (b)(6) 2011 during the index procedure.The type 3b endoleak is mostly likely device related due to the use of strata material.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; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.No additional investigation of this reported event is planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

Event Description

At the completion of the clinical assessment on 12/06/2018, for a previous report event (2031527-2018-00886), clinical was able to find substantial evidence to support the following additional findings of implant separation, stent cage dilation and stent migration of the suprarenal stent graft extension implanted on (b)(6) 2011.This complaint is for the suprarenal stent graft extension implanted on (b)(6) 2011 only,.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 8220432
• MDR Text Key: 132194379
• Report Number: 2031527-2019-00012
• 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
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2018

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: 06/30/2012
• Device Model Number: A34-34/C80-O20
• Device Lot Number: W11-3592-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR