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

Model Number BA22-90/I16-30

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

Patient Problem Failure of Implant (1924)

Event Date 09/26/2017

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

The patient was initially implanted with a bifurcated and suprarenal device in 2012.On (b)(6) 2017, the patient presented his recent ct to the physician.An endoleak type iiia with complete component separation was observed.The physician elected to reline with a vela cuff and ovation to successfully resolve the leak.No additional patient sequela has been reported.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received, there were evidence to support the reported endoleak.It was confirmed that patient had an el3a; a complete component separation; and a secondary endovascular intervention.In addition, a stent cage dilation of the cuff (reported in a separated report) and main body stent,( 24% and 36% respectively).The most likely cause of the loss of seal and implant separation was the use of strata material in combination[ due to the presence of stent cage dilation] with severe aortic remodeling (anatomy).The patient's disposition post repair could not be ascertained; there were no further reports of negative patient sequelae.The review of manufacturing lot confirmed all devices met specifications prior to release.The lot usage history shows that no other units from the affected lots have been involved in any similar complaints at this time.No device will be returned as the device remains implanted in the patient.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.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Type of Device: BIFURCATED 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: 6967026
• MDR Text Key: 89914840
• Report Number: 2031527-2017-00542
• 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: 09/27/2017

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: 09/30/2012
• Device Model Number: BA22-90/I16-30
• Device Lot Number: W11-5098-013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/20/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR