MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA28-100/I16-40

Device Problems Collapse (1099); Hole In Material (1293); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 01/23/2017

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

It was reported the patient had an initial procedure with a bifurcated stent.On (b)(6) 2017 a follow up computed tomography (ct) showed a type 3b endoleak at the bifurcation of the stent graft.A secondary procedure was not reported as completed or scheduled for this patient.The patient is reported to be in stable condition.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm the reported event.In addition there was evidence to support a stent collapse, placement of non-endologix stents in the renal arteries, and an occlusion of the non-endologix stents.The clinical evaluation additionally identified the following contributing factors to the reported event; off label use due to patient anatomy, the use of non-endologix stents, and an early stent cage collapse above the bifurcation.The review of the manufacturing lot confirmed all devices met specifications prior to release.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 less than 0.2%.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6387423
• MDR Text Key: 69366922
• Report Number: 2031527-2017-00098
• 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: 02/08/2017

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: No Information
• Device Expiration Date: 10/31/2015
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1047127-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR