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

Model Number BEA28-90/I20-30

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Detachment Of Device Component (1104); Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 06/16/2017

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 had a doppler ultrasound and a type 3a endoleak was visible.It appeared that the main afx body and the aortic cuff were completely separated.A secondary procedure, was performed on (b)(6) 2017, during the intervention, 2 vela infrarenals and 1 vela suprarenal were implanted in the patient.They placed 3 total new aortic cuffs to accommodate the long aortic length and to acquire enough overlap.Post angiogram showed great results with no endoleak.Patient did fine during procedure and went home the following day.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events;a secondary procedure and a type iiia endoleak (complete component separation).Additional findings include a type iiib main body stent cage dilation 34.8mm (24%); original implants included sr cuff- ir cuff- bil non-afx limb ext (bare metal)-lcia afx limb.The most likely cause of the mid aortic loss of seal, complete component separation, compromised stent graft integrity (stretched [24%]), procedure related harms and final patient disposition could not be ascertained due to the lack of the medical information surrounding the implant procedure and the secondary endovascular procedure.Reportedly, patient was in stable condition and discharged home on the second post- operative day after the repair procedure.To date there has been no reports of further negative patient sequalae.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.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 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.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%.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC; 2 musick; irvine CA 92618
• MDR Report Key: 7445521
• MDR Text Key: 106002430
• Report Number: 2031527-2018-00348
• 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,other
• Type of Report: Initial,Followup
• Report Date: 06/16/2017

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: Health Professional
• Device Expiration Date: 02/04/2017
• Device Model Number: BEA28-90/I20-30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIMB STENT GRAFT , 2 VELA CUFFS
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR