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

Model Number A34-34/C80-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 11/02/2017

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 in 2012 with a bifurcated and suprarenal device.During a follow up ct, it was discovered that the patient had and endoleak type iiia with aneurysm growth.Secondary was completed (b)(6) 2017; the physician elected to implant a vela suprarenal device.No additional patient sequelae has been reported at this time.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; endoleak type iiia and sac growth.Additionally there was evidence to reasonably support the following observations; dilation of the main body and stent cage, and complete component separation of the main body and cuff.The most likely cause of the loss of seal and component separation of the main body and the cuff was the aortic remodeling.The most likely cause of the main body and cuff stent cage dilation was the use of strata material in combination with the progressive loss of overlap.Procedure related harms included additional intervention to place a drain for a seroma collection.Patient was discharged home on the third post-operative day.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; 1.Patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; 2.Patient conditions including disease progression or anatomical changes post implant; 3.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; 1.Sizing guidance and instructions were updated in the ifu and released on (b)(6) 2015, 2.Field training was completed by (b)(6) 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.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.

• 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: 7068408
• MDR Text Key: 93246825
• Report Number: 2031527-2017-00646
• 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: 01/31/2018

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: 11/30/2012
• Device Model Number: A34-34/C80-O20
• Device Lot Number: W11-4841-029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/29/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2011
• 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
• Treatment: AFX-SUPRARENAL-LOT: W11-4841-029
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR