MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I16-40

Device Problems Collapse (1099); Hole In Material (1293); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 07/03/2017

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

A patient was initially implanted with a bifurcated stent, an infrarenal aortic extension and a limb stent to repair an abdominal aortic aneurysm.A follow up computed tomography angiogram (cta) on (b)(6) 2017 showed the patient had a possible type 3b endoleak of the main body graft.The patient is asymptomatic and reported to be in stable condition.The physician is planning a reline of the original implanted devices.A subsequent endovascular procedure has not reported to endologix and to date it is unknown if a secondary intervention has been scheduled.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical assessment was able to confirm a type 3b endoleak of the main body and stent collapse of the proximal main body device.The most likely cause of the type 3b endoleak was the use of strata material in combination with progressive remodeling and stent collapse of the main body stent.Also the pre-existing severe calcification in the distal aorta and bilateral iliac likely contributed to this event (cautionary product use condition).No procedure related issues, user related issues, off-label product use or procedure related harms could be determined due to lack of medical imaging and information surrounding the implant and repair procedures.The event devices remain implanted in the patient and were not available for further evaluation.The review of the manufacturing lot confirmed all devices met specifications prior to release.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%.No additional investigations of this reported complaint are planned, endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

Event Description

The patient had a secondary procedure completed on (b)(6) 2017.The physician elected to implant an additional bifurcated stent and a suprarenal aortic extension.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 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: 6769430
• MDR Text Key: 81899022
• Report Number: 2031527-2017-00400
• 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: 07/07/2017

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: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1055813-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 10/20/2017
• Supplement Dates FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2014
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR