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

Model Number BA25-80/I13-40

Device Problems Leak/Splash (1354); Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/17/2018

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

Patient was initially treated on (b)(6) 2012 with an afx bifurcation and cuff.On (b)(6) 2018, patient went in for a secondary procedure for an unknown reason and a vela proximal graft was placed.The reason for the secondary procedure has not been reported.Patient condition is reported to be good post op.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were reported evidence that supported the following case event.Clinical was able to confirm the endoleak type 3a (with complete component separation).In addition, patient also had a stent cage dilation of the cuff (21%) and of the main body stent (20%).Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the mid aortic loss of seal with complete implant separation, could not be determined.However the stent cage dilation of both the cuff and the main body stents (compromised stent graft integrity- stretched) likely contributed to this event.The stretched fabric was likely related to the use of strata fabric.Procedure related harms and the final patient disposition could not be determined due to the lack of medical information surrounding the implant and repair procedures.Reportedly, the patient was doing well post the endovascular repair.There have been no reports of further negative patient sequelae.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 (b)(6) 2015, 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.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.(b)(4).

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7277332
• MDR Text Key: 100303715
• Report Number: 2031527-2018-00088
• 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: 01/17/2018

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?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2015
• Device Model Number: BA25-80/I13-40
• Device Lot Number: 1046708-003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA Received: 04/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUFF, LOT 1050124-026; CUFF, LOT 1050124-026
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR