MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; PRODUCT FAMILY (PRIMARY): D1 PRODUCT DESCRIPTION (PRIMARY): D2 SUPRARENAL AO

Model Number A25-25/C95-O20

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Inadequacy of Device Shape and/or Size (1583); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Unintended Movement (3026)

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

Event Date 09/21/2017

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

Patient was initially implanted with an afx bifurcated and suprarenal device on (b)(6) 2013.It was noted that the original implant, the main body was too short.Approximately 4 years post implant, it was noted that the overlap was insufficient along with an endoleak type iiia, and there was aneurysm growth.On (b)(6) 2017 the patient underwent a reline with 2 gore c tag thoracic graft.No additional patient sequalae was reported.

Manufacturer Narrative

Clinical evaluations was unable to find substantial evidence to support the following reported events; secondary procedure and sac growth.The reported endoleak type iiia was refuted, rather there were evidence to support and endoleak type iiib of the cuff.Additionally there was evidence to reasonably support the following observations; stent cage dilation of the main body and suprarenal cuff.The most likely cause of the compromised stent graft integrity of the cuff (stretched [28%] and breached) was the use of strata material in combination with the aorta remodeling that resulted in loss of overlap.Also a contributing factor was the off-label neck anatomy (if current date standards were applied).No intentional user was detected since the neck was in specification at the time of the implant.Notably, the superior stent margin of the main body stent was also dilated to 35%; the most likely cause was the use of the strata material.The procedure-related harms and final patient disposition could not be ascertained due to lack of medical information surrounding the event.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; 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 (b)(6) 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%.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; 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 (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%.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.(b)(4).

• Brand Name: AFX
• Type of Device: PRODUCT FAMILY (PRIMARY): D1 PRODUCT DESCRIPTION (PRIMARY): D2 SUPRARENAL AO
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7061871
• MDR Text Key: 93029767
• Report Number: 2031527-2017-00640
• 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,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/30/2015
• Device Model Number: A25-25/C95-O20
• Device Lot Number: 1041866-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2012
• 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