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

Model Number BA28-90/I20-30

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 12/29/2016

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

The patient was implanted with an afx bifurcated stent graft, vela suprarenal, and a limb stent graft on (b)(6) 2015.At a later date, the patient presented with a limb separation and type 3a endoleak, but was asymptomatic.The secondary case was completed on (b)(6) 2017 and an ovation extender was implanted.No devices were explanted and patient was doing well after procedure.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there were substantial evidence to support the following reported event: the type iiia endoleak with component separation is confirmed and is most likely user-related.Procedure-related harms for this complaint could not be determined.The final patient status was doing well.The clinical assessment determined that there was evidence to reasonable suggest stent cage dilation of the main body stent that was not included in the event as reported.The finding was discovered on (b)(6) 2018, during review of the ct of (b)(6) 2016, 19 months post-implant.There was also evidence of off label diameter lcia; severe ca iliacs.The manufacturing lot review 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.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.Therapy dates (b)(6) 2015.Remove result code 3221.Add device code 1601.Add method code 4117.Add result code 213.Add conclusion code 24.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7445708
• MDR Text Key: 106004872
• Report Number: 2031527-2018-00187
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)171013
• 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: 01/03/2017

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: 10/13/2017
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251907-029
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 01/03/2017
• Supplement Dates FDA Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-LIMB STENT GRAFT - LOT 1252566-002; AFX-VELA SUPRARENAL - LOT 1252465-003
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR