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

Model Number A34-34/C100-O20

Device Problems Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354); Migration or Expulsion of Device (1395); Off-Label Use (1494); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Pain (1994); Rupture (2208)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; urgent presentation, rupture, open repair, sac growth, and explant.Additionally there was evidence to reasonably support the following observations; endoleak type ia, type iiib and dilation of the cuff, and type iiib and dilation of the main body of the main body (covered in report: 2031527-2017-00652).The most likely cause of the proximal loss of seal was the off label neck anatomy (intentional user error) at the initial implant in combination with the stent migration.The most likely cause of the stent migration (50mm) and the compromised stent graft integrity of the cuff (stretched [41%] and breached) was the use of strata material in combination with the off-label neck anatomy (intentional user error).Reportedly the patient had an open repair procedure to explant the device during the rupture event.Patient was also reported to be in stable condition post the explant.To date there has been no reports of further negative 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 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 <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 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 <0.2%.Device was not returned, therefore, sample evaluation was not 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.

Event Description

During the clinical evaluation of this complaint completed on (b)(6) 2018; it was discovered that the patient also had an endoleak type ia, type iiib of the cuff, and migration along with an endoleak type iiib of the main body.This report will cover the failure associated with the cuff, and the endoleak type iiib of the main body will be reported in report # 2031527-2017-00652.

• Brand Name: AFX
• Type of Device: SUPRARENAL 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: 7253012
• MDR Text Key: 99573250
• Report Number: 2031527-2018-00077
• 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: 02/06/2018

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: Physician
• Device Expiration Date: 05/30/2016
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1047255-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/09/2013
• 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: 70 YR