MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C100-O20

Device Problems Failure To Adhere Or Bond (1031); Stretched (1601); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Stenosis (2263)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

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 july 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%.

Event Description

Upon clinical assessment of the event reported under 2031527-2017-00605, it was discovered that there was a stent cage dilation and 7 mm of movement of the cuff.Based on the clinical assessment for this event, the most likely cause of stent movement was found to be device related due to the dilation of the cuff diameter over time.The low, but adequate placement of the cuff at implant also likely contributed to the movement.The most likely cause of the compromised stent graft integrity of the cuff was found o be device related due to the use of strata material.Due to the lack of medical information surrounding the repair event, procedure-related harms and the final patient disposition could not be determined.There have been no reports of further patient sequelae.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7341978
• MDR Text Key: 102500276
• Report Number: 2031527-2018-00180
• 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: 01/18/2018

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: 04/30/2016
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1047252-012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2013
• 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: BIFURCATED STENT GRAFT: BA28-90/I20-30; INFRARENAL AORTIC EXTENSION: A34-34/C80; LIMB STENT GRAFT: I20-13/C88F SA; LIMB STENT GRAFT: I20-13/C88F SA
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR