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

Model Number A34-34/C80-O20

Device Problems Fracture (1260); Hole In Material (1293); Leak/Splash (1354); Migration or Expulsion of Device (1395); Material Rupture (1546); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Rupture (2208)

Event Date 11/02/2017

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.

Event Description

An afx bifurcated and a vela suprarenal were implanted to treat an abdominal aortic aneurysm.The patient presented approximately 5 years post-op with a symptomatic ruptured aaa s/p afx repair elsewhere.A re-intervention was performed where the stent graft was relined on (b)(6) 2017.The device was noted to have stent fractures and obviously a fabric tear given rupture.As of the date of this report, the patient condition is reported as good and there have been no additional patient sequelae reported.

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received there were substantial evidence to support the following reported events; rupture and secondary endovascular procedure with non endologix stent.Clinical evaluations was unable to find substantial evidence to support the following reported events; type iiib endoleak, stent fracture, and patient in favorable condition.Additionally there was evidence to reasonably support a stent migration of the cuff.The most likely cause of the compromised stent graft integrity is the reported stent fracture, likely associated with aortic remodeling which was a result of the off label aortic neck angulation.This remodeling also was the likely cause of the stent migration.Procedure related harms and the final patient disposition could not be determined.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; 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 iiib endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at (b)(4)%.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; 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 (b)(4)%.Since the corrective actions were implemented, the type 3b endoleak events reported for afx devices has been reduced to <0.2%.Devices remain implanted in the patient and were not returned, no evaluation completed.The review of manufacturing lot confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7071137
• MDR Text Key: 93344987
• Report Number: 2031527-2017-00648
• 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: 11/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• 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/C80-O20
• Device Lot Number: 1025849-029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2012
• 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-SUPRARENAL-LOT: 1025849-029
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR