MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-90/I20-30

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Detachment Of Device Component (1104); Leak/Splash (1354); Stretched (1601)

Patient Problem Failure of Implant (1924)

Event Date 09/28/2015

Event Type  Injury  

Manufacturer Narrative

At the completion of the clinical evaluation, based on the information received, the clinical evaluation refuted the reported type 2 endoleak.However, a type 3a endoleak with complete component separation was confirmed through patient imaging.No procedure related issue, user related issue, anatomy related issue, or contributing cautionary including off-label product use conditions could be determined due to lack of information surrounding the event.The remodeling of the system as the devices separated likely caused a stent graft collapse of the main body.Currently, there have been no reports of further negative patient sequelae; there has been no evidence of a repair procedure.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 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 3a events have been reduced significantly and are well within the acceptable range per our risk assessment.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 was initially implanted with a bifurcated stent and a suprarenal aortic extension.It was reported the patient was diagnosed with a type 2 endoleak that was not treated.Through clinical evaluation of this reported event it was discovered the patient had a type 3a endoleak with complete component separation.There have been no reports of the patient having a secondary procedure.The patient condition remains unknown.To date there have been no additional adverse events reported to endologix for this patient.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: michelle caulfield ; 2 musick; irvine, CA 92618 ; 9495984606
• MDR Report Key: 6843887
• MDR Text Key: 84934947
• Report Number: 2031527-2017-00449
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2015

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: 09/30/2014
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1101192-027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2013
• 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): Other
• Patient Age: 80 YR
• Patient Weight: 80