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

Model Number BA25-120/I20-40

Device Problems Hole In Material (1293); Leak/Splash (1354); Inadequacy of Device Shape and/or Size (1583); Stretched (1601)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Pain (1994)

Event Date 10/17/2017

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

Patient was initially implanted with afx devices to treat and aortic aneurysm in 2013.Recently, the patient returned with abdominal pain and it was discovered that patient had an increase in sac size.The physician noted an endoleak type iiib.On (b)(6) 2017, the physician relined with a main body and aortic extension to successfully resolve the endoleak.Patient status was reported as doing well post secondary procedure.

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 iiib of the main body, abdominal pain, aneurysm enlargement, and reline with a main body and infrarenal cuff.Additionally there was evidence to reasonably support the following observation; dilation of the main body stent.The most likely cause of the compromised stent graft integrity was related to the strata graft material.Additionally the off-label placement of an oversized cuff into a smaller main body likely contributed to the event.Associated clinical harms for this event included: pain, aneurysm enlargement, type iiib endoleak, and a secondary endovascular procedure-reline.The final patient disposition was discharged home post secondary procedure day two in stable condition.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 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; 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%.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.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618
• MDR Report Key: 7018674
• MDR Text Key: 91769901
• Report Number: 2031527-2017-00595
• 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: 01/16/2018

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: 07/30/2017
• Device Model Number: BA25-120/I20-40
• Device Lot Number: 1111627-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 11/10/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR