MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA25-110/I16-30

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problems Aneurysm (1708); Failure of Implant (1924); No Code Available (3191)

Event Date 12/02/2016

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.Devices remain implanted in the patient.

Event Description

It was reported the patient had an initial procedure on (b)(6) 2013 with a bifurcated stent, an infrarenal aortic extension, and a suprarenal aortic extension.On (b)(6) 2015 a follow up computed tomography (ct) scan showed aneurysm sac growth and a potential type 3b endoleak near the graft bifurcation.A secondary intervention has not been scheduled.The patient is not symptomatic and there have been no additional adverse events reported.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received the following were confirmed; aneurysm sac growth, an endoleak type iiib of the main body.Additionally there was evidence to reasonably support the following observations; right iliac artery stent placed for a chronic dissection causing a stenosis, left groin seroma, left common femoral artery dissection, dilation of the superior stent margin of the main body, and secondary procedure of a relining with a main body and 2 proximal extensions.The clinical assessment was based on suboptimal patient medical records, and no patient images.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned, no evaluation completed.Based on the information available the root cause of the reported event is unknown.Devices remain implanted in the patient and were not returned, no evaluation completed.Clinical found evidence to reasonably suggest the following contributing factors to the reported event; antiplatelet therapy, left common femoral artery was used as the ipsilateral insertion site contributing to the dissection.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b 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 3b 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 3b endoleak events reported for afx devices has been reduced to <0.2%.Correction: contact office- name.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 8009832284
• MDR Report Key: 6216908
• MDR Text Key: 63687872
• Report Number: 2031527-2016-00601
• 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: 12/02/2016

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: 01/31/2014
• Device Model Number: BA25-110/I16-30
• Device Lot Number: 1101362-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/31/2016
• Supplement Dates Manufacturer Received: 12/02/2016
• Supplement Dates FDA Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2016
• 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
• Treatment: AORTO UNI-ILIAC [INFRARENAL]- (B)(4); AORTO UNI-ILIAC [SUPRARENAL]- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR