MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C100-O20

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Leak/Splash (1354); Stretched (1601)

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

Event Date 11/09/2017

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

An afx bifurcated and a vela suprarenal extension were implanted to treat an abdominal aortic aneurysm.In reviewing the ct from 2015 to 2017 it was noted that the aneurysm grew form 4.6 to 6.3 cm.Upon review of the ct, it was noted that there was no apparent leak but the diameter of the cuff has dilated 5 cm.Patient is scheduled for a secondary on (b)(6) 2017.Currently, there has been no additional patient sequelae 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; sac growth and proximal stent dilation of the cuff.Clinical evaluations was unable to find substantial evidence to support the following reported events; secondary procedure, intraoperative type ia endoleak treated with proximal coiling with partial resolution and patient being monitored.Additionally there was evidence to reasonably support the following observations; stent cage dilation of the main body, and endoleak type iiia with complete component separation.The most likely cause of the compromised stent graft integrity of both the cuff (25%) and the main body stent (24%) was the use of the strata material.This dilation was likely the main cause of the loss of seal and implant separation of afx products.This dilation likely contributed to the inability to exclude the aneurysm upon ovation re-line and the unsuccessful coiling (sac and/or lumbar) for the resistant intraoperative proximal loss of seal (intentional user error) that was still present thirty days after the repair procedure.The final patient disposition was reported to be stable and being monitored.There have been no further reports of negative patient sequelae.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type iiia endoleak.The root causes have been identified as; patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; patient conditions including disease progression or anatomical changes post implant; off label product use including patient anatomy, overlap length, oversizing between components, and placement of the devices within the anatomy of the patient.Endologix implemented the following corrective actions to reduce the type iiia endoleak events; sizing guidance and instructions were updated in the ifu and released on 06/17/2015, field training was completed by 08/03/2015.Since the corrective actions were implemented the type iiia events have been reduced significantly and are well within the acceptable range per our risk assessment.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

Event Description

Patient received a relined on (b)(6) 2017 with an ovation graft.At the end of the procedure the physician noted an endoleak type i and coils were placed to slow the leak.Patient was discharged home the following day.No additional patient sequalae reported.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7082914
• MDR Text Key: 93728235
• Report Number: 2031527-2017-00655
• 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: 02/07/2018

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: 01/31/2016
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1047244-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2013
• 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
• Treatment: AFX-BIFURCATED-LOT: 1046779-009
• Patient Age: 68 YR