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

Model Number BA22-80/I16-40

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

Patient Problem Failure of Implant (1924)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.

Event Description

On (b)(6) 2018, endologix was informed during a follow up ct on a patient had a large type 3a endoleak that was due to a separation of the main body and aortic extension.The patient was originally implanted with an afx for a aaa in (b)(6) 2014.A planned re-intervention will be done and patient will be treated with a thoracic body or a aorto uniliac device.No date had been provided as to when the re-intervention will be performed.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were reported evidence that supported the following case event.Clinical was able to confirm the reported endoleak type 3a with complete component separation.In addition, clinical also noted stent cage dilation of both the main body and cuff stent cage (stretched- 31%) with indeterminate endoleak involving one or both components.The most likely cause of the compromised stent graft integrity of the cuff and main body was the use of strata material in combination with the loss of overlap.Due to the lack of surveillance imaging, the most likely cause of the loss of seal, implant separation, and indeterminate endoleak of either the cuff or main body stent could not be determined.In addition, the impending intervention, procedure-related harms, and the condition of the patient could not be ascertained due to the lack of medical information surrounding the event procedure.To date, no intervention or reports of further negative patient sequelae have been received.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, 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 review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and will not returned and no evaluation will be completed.These types of events will be monitored and trended as part of the quality system.

Event Description

Based on clinical's final assessment, patient also had a stent cage dilation of both the main body and cuff stent cage (stretched- 31%) and an indeterminate endoleak involving one or both components.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7277350
• MDR Text Key: 100305898
• Report Number: 2031527-2018-00096
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

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: 11/30/2016
• Device Model Number: BA22-80/I16-40
• Device Lot Number: 1055768-021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRODUCER SYSTEM II, LOT 1226941-020; SUPRARENAL AORTIC EXTENSION, LOT 1047322-025; INTRODUCER SYSTEM II, LOT 1226941-020; SUPRARENAL AORTIC EXTENSION, LOT 1047322-025
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR