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

Model Number BA28-100/I16-40

Device Problems Hole In Material (1293); Leak/Splash (1354); Stretched (1601)

Patient Problem Failure of Implant (1924)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical assessment was able to confirm a type 3b endoleak of the main body and proximal cuff devices.Additionally a clinical evaluation was able to identify a dilation of the main body stent and refute the dilation of the suprarenal stent.The most likely cause of the type 3b endoleak of the main body and cuff was related to the use of strata material.There were no procedure related harms identified due to the lack of medical information surrounding both the implant and the event.To date the patient has not had a secondary procedure.The event devices remain implanted in the patient and were not available for further evaluation.The review of the manufacturing lot confirmed all devices met specifications prior to release.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

Event Description

The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.It was reported the patient had a dilation of the suprarenal cuff.At the completion of a clinical evaluation it was discovered the bifurcated stent was dilated and had a type 3b endoleak.A secondary procedure has not been completed or scheduled for this patient.The patient has been reported to be doing well and is currently in stable condition.There have been no additional adverse events reported for this patient.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7204925
• MDR Text Key: 97711375
• Report Number: 2031527-2018-00041
• 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
• Report Date: 01/15/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: BA28-100/I16-40
• Device Lot Number: W11-3950-009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2018
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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: SUPRARENAL AORTIC EXTENSION- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR