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

Model Number BA25-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 12/05/2017

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 stent and two suprarenal aortic extensions.A follow up showed the patient had a type 3 endoleak.On (b)(6) 2017 the patient had a secondary intervention and the physician elected to reline the initial implanted devices with ovation devices.At the completion of the secondary intervention the patient is reported to be in stable condition.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.It was confirmed that patient had a type iiib endoleak of the main body.Patient had a secondary endovascular procedure done on (b)(6) 2017.In addition, clinical also noted that the main body had a superior stent cage dilation 30.3mm (20%) and sac growth.Patient was reported to be in stable condition post surgery.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 compromised stent graft integrity of the main body (stretched (20%) and breached) was the use of the strata material.No procedure related harms detected.Patient was discharged in stable condition on the second post-operative day.Notably, at the initial implant procedure stent migration of the cuff was noted, which resulted in type ia endoleak that was successfully treated with additional supra renal cuff.The devices remain implanted in the patient and were not returned and no evaluation was completed.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; upgraded graft material (i.E.Duraply) and updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place (b)(6) 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.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation will be completed.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: 7162680
• MDR Text Key: 96324059
• Report Number: 2031527-2018-00003
• 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: 12/05/2017

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: 08/31/2012
• Device Model Number: BA25-100/I16-40
• Device Lot Number: W11-4645-006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUPRARENAL AORTIC EXTENSION- (B)(4); SUPRARENAL AORTIC EXTENSION- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR