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

Model Number BA28-90/I20-30

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Hole In Material (1293); Leak/Splash (1354); Stretched (1601); Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

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

The patient was initially implanted with a bifurcated stent, a suprarenal aortic extension, an infrarenal aortic extension and two limb extensions.A routine follow up computed tomography (ct) showed the patient had a type 3a endoleak or a possible type 3b endoleak.A secondary intervention was completed and the patient was reported to have a type 3a endoleak with component separation between the main body and left iliac limb extension.The physician implanted two additional limb extensions to bridge the initial limb extension and the main body graft.The patient is reported to be doing well post procedure.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

At the completion of the complaint investigation and based on the information received, the clinical evaluation was able to confirm a type 3a endoleak of the bifurcated stent and a limb extension.Additionally the clinical evaluation identified a dilation and movement of the proximal cuff as well as a dilation and type 3b endoleak of the main body.The most likely cause of the distal type 3a endoleak with complete component separation was the off-label, tortuous iliac anatomy (intentional user error).The most likely cause of the type 3b endoleak of the main body stent (breached and stretched fabric) was the use of strata material in combination with aggressive ballooning at implant to resolve an intraoperative endoleak, and the loss of overlap at both the distal and proximal sites.The most likely cause of the stent movement of the cuff was a combination of a low, but adequate placement of the cuff at implant and the dilation of the cuff diameter over time.The most likely cause of the compromised stent graft integrity of the cuff (stretched fabric) was the use of strata material.There was approximately a 50% aortic stenosis caused by intra-stent mural thrombus within the cuff and main body stents.Due to the lack of medical information surrounding the repair event, procedure-related harms and the final patient disposition could not be determined.There have been no reports of further negative patient sequelae.The manufacturing lot review 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 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, 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.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 (b)(6) 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%.(b)(4).

• 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 ; 9495984671
• MDR Report Key: 7035754
• MDR Text Key: 92155391
• Report Number: 2031527-2017-00605
• 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: 04/30/2018

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: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1101187-027
• 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: 11/15/2017
• Supplement Dates Manufacturer Received: 10/17/2017
• Supplement Dates FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2013
• 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: 81 YR