MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA22-90/I20-30

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Hole In Material (1293); Leak/Splash (1354); Stretched (1601); Deformation Due to Compressive Stress (2889)

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

Event Date 09/06/2017

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 in 2015 with and afx bifurcated and suprarenal stent.Approximately two years post implant on (b)(6) 2017, during an annual follow up, it was discovered that the patient had and endoleak type 3a with component separation.On (b)(6) 2017, the patient underwent an intervention and the physician elected to implant the patient with a bifurcated and infrarenal extension to resolve the leak.The patient was reported to be doing well post 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; type iiia component separation.The following reported reline with a bifurcated stent was refuted, rather there were 3 additional cuff placed.Additionally there was evidence to reasonably support the following observations; stent cage dilation 84% of the cuff, endoleak type iiib of the cuff, main body stent collapse (100%), three days post repair at 24 months which included sac growth, possible el iiib verses fabric billowing at the bifurcation (possible persistent leak).Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the loss of seal and complete implant separation was the use of strata material and the resultant compromise stent graft integrity [breached and stretched-84%] of the cuff.The most likely cause of the main body stent buckling (100%) was due to the lateral movement of the cuff.Additionally, the tortuous aortic angulation observed at 24 months likely contributed to this event (anatomy-related issue).However, it could not be determined if this was a pre-existing off-label, and/or cautionary product use condition, verses lateral movement overtime.No procedure-, and/or user-related issues, could be determined due to lack of medical information surrounding the initial implant.Associated clinical harms for this device malfunction included: sac growth; type iiia endoleak (aortic); type iiib of the cuff and secondary endovascular procedure.It was reported that the patient was in stable condition post-secondary endovascular procedure.However, there was additional finding of sac growth three days post implant (possible unresolved endoleak).There were 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 iiia endoleak.The root causes have been identified as; patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; patient conditions including disease progression or anatomical changes post implant; off label product use including patient anatomy, overlap length, oversizing between components, and placement of the devices within the anatomy of the patient.Endologix implemented the following corrective actions to reduce the type iiia endoleak events; sizing guidance and instructions were updated in the ifu and released on 06/17/2015, 2.Field training was completed by 08/03/2015.Since the corrective actions were implemented the type iiia events have been reduced significantly and are well within the acceptable range per our risk assessment.Root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3a endoleak.The root causes have been identified as; patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; patient conditions including disease progression or anatomical changes post implant; off label product use including patient anatomy, overlap length, oversizing between components, and placement of the devices within the anatomy of the patient.Endologix implemented the following corrective actions to reduce the type 3a endoleak events; sizing guidance and instructions were updated in the ifu and released on 06/17/2015, 2.Field training was completed by 08/03/2015.Since the corrective actions were implemented the type 3a events have been reduced by 95%.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 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%.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: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6947888
• MDR Text Key: 89274751
• Report Number: 2031527-2017-00514
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012272
• UDI-Public: (01)00818009012272(17)17112
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 09/11/2017

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: 11/24/2017
• Device Model Number: BA22-90/I20-30
• Device Lot Number: 1290518-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 09/11/2017
• Supplement Dates FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2014
• 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: 1026625-029
• Patient Outcome(s): Required Intervention