MAUDE Adverse Event Report: ENDOLOGIX AFX; INFRARENAL AORTIC EXTENSION

Model Number A34-34/C100

Device Problems Failure To Adhere Or Bond (1031); Hole In Material (1293); Leak/Splash (1354); Stretched (1601); Unintended Movement (3026)

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

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; endoleak type ia, iiia with component separation, endoleak type iiib of the cuff, and secondary procedure.Additionally there was evidence to reasonably support the following observations; cuff dilation, and stent cage dilation of and buckling of the main body with sac growth (reported in #2031527-2018-00184).The most likely cause of the compromised stent graft integrity of the cuff (stretched and breached) was the use of strata material in combination with possible damage to the overlap region during implant.The most likely cause of the cuff migration, implant separation, loss of proximal and mid aortic seal, and, the main body stent buckling was the stent cage dilation of cuff.Procedure related harms and the final patient disposition could not be ascertained.There has been no reports of further negative patient sequelae.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; 1.Upgraded graft material (i.E.Duraply) and 2.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 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%.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; 1.Upgraded graft material (i.E.Duraply) and 2.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%.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

Event Description

Patient was initially implanted with an bifurcated and infrarenal device in 2013.Recently, patient had a cta performed which showed a graft migration, endoleak type iiia, and type ia (reported in report:2031527-2018-00184) patient underwent a secondary procedure on (b)(6) 2018, the physician elected to implant a non-endologix main body and two non-endologix limbs.Patient was discharged 24 hrs after the procedure.During the clinical evaluation of this complaint, it was discovered that the issue was in the infrarenal device.

• Brand Name: AFX
• Type of Device: INFRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7569625
• MDR Text Key: 110091385
• Report Number: 2031527-2018-00508
• 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: 03/01/2018

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: Physician
• Device Expiration Date: 09/30/2015
• Device Model Number: A34-34/C100
• Device Lot Number: 1026649-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2012
• 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
• Treatment: AFX-BIFURCATED-LOT: 1047065-009
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR