MAUDE Adverse Event Report: ENDOLOGIX INC. AFXBIFURCATED STENT GRAFT

Model Number BA25-110/I16-30

Device Problems Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354); Inadequacy of Device Shape and/or Size (1583); Stretched (1601)

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

Event Date 10/27/2017

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 initially implanted with a bifurcated and suprarenal device in 2013.Recently, the patient was admitted to er with a ruptured aneurysm.The physician elected to explant the device and noted that the patient had a juxtarenal aneurysm in a very reverse tapered neck with no wall apposition and no apparent endoleak seen.The patient is doing well post explant procedure.No additional patient sequelae has been reported.

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 (will be reported in a separate report), and type iiib and dilation of the main body of the main body.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 compromised stent graft integrity (stretched and breached) of the main body was the use of strata material in combination with the off-label use with the oversized cuff.Procedure-related harms could not be detected due to lack of medical information surrounding the event.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.(b)(4).

• Brand Name: AFXBIFURCATED STENT GRAFT
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7074883
• MDR Text Key: 93461613
• Report Number: 2031527-2017-00652
• 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: 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: 03/30/2014
• Device Model Number: BA25-110/I16-30
• Device Lot Number: 1101363-008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/01/2017
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX SUPRARENAL-LOT: 1047255-010; AFX SUPRARENAL-LOT: 1047255-010
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR