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)

Patient Problem Failure of Implant (1924)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

On (b)(6) 2013, the patient was implanted with a bifurcated stent and a suprarenal extension to treat an abdominal aortic aneurysm.On 04/03/2018, endologix was made aware of a type 3a endoleak with implant separation.The physician elected to implant an ovation main body with two (2) lilac limbs to resolve this event.There have been no additional patient sequelae reported.

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following reported event of a type 3a endoleak with component separation of the suprarenal extension (cuff) and the bifurcated stent (main body).Additionally clinical also found evidence of stent cage dilation of 22% of the cuff.This complaint is most likely anatomy related as there was a severely angulated neck (off -label).Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.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 06/17/2015, 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.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.Correction: common device name, model number, lot #, expiration date, concomitant medical products and therapy dates, and device manufacture date.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7473479
• MDR Text Key: 106918759
• Report Number: 2031527-2018-00392
• 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: 04/03/2018

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: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1026337-016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIFURCATED STENT, LOT # 1100962-004; SUPRARENAL EXTENSION, LOT # 1026337-016; SUPRARENAL EXTENSION, LOT # 1026337-016
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR