MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; SUPRARENAL AORTIC EXTENSION

Model Number A34-34/C100-O20

Device Problems Failure To Adhere Or Bond (1031); Partial Blockage (1065); Leak/Splash (1354); Occlusion Within Device (1423); Stretched (1601); Detachment of Device or Device Component (2907); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Thrombus (2101)

Event Date 10/16/2017

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 with and afx bifurcated and suprarenal device.Patient came in for a routine follow up and it was discovered that there was an endoleak type iiia, dilation of the cuff, and aneurysm growth.Patient is scheduled for an intervention (b)(6) 2017.There has been no additional patient sequelae reported at this time.

Manufacturer Narrative

Clinical evaluations was unable to find substantial evidence to support the following reported events; endoleak type iiia with complete separation, suprarenal stent dilation at inferior stent margin, and intragraft thrombus in the suprarenal cuff.Additionally there was evidence to reasonably support the following observations; aneurysm enlargement, and distal movement of the suprarenal cuff.The most likely cause of the loss of seal and stent dilation could not be determined.The distal suprarenal stent movement (~4mm) likely contributed to the loss of seal.Associated clinical harms for this event included: type iiia endograft, aneurysm enlargement, and secondary endovascular procedure.The final patient disposition was unknown, there have been no additional negative patient sequelae reported.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; 1.Patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; 2.Patient conditions including disease progression or anatomical changes post implant; 3.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 (b)(6) 2015, field training was completed by (b)(6) 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.The review of manufacturing lot confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not returned, no evaluation completed.Endologix continues to investigate this event and similar events to ensure the highest (b)(4).

Manufacturer Narrative

Based on the reported event and provided medical records clinical assesment was unable to find substantial evidence to support the following reported events; endoleak type iiia with complete separation, suprarenal stent dilation at inferior stent margin, and intragraft thrombus in the suprarenal cuff.However, there was evidence to reasonably support the following observations; aneurysm enlargement, and distal movement of the suprarenal cuff.The most likely cause of the loss of seal and stent dilation could not be determined.The distal suprarenal stent movement (~4mm) likely contributed to the loss of seal.Associated clinical harms for this event included: type iiia endograft, aneurysm enlargement, and secondary endovascular procedure.The final patient disposition was unknown, there have been no additional negative patient sequelae reported.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.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.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7014408
• MDR Text Key: 91496134
• Report Number: 2031527-2017-00591
• 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,Followup
• Report Date: 10/16/2017

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: 05/30/2016
• Device Model Number: A34-34/C100-O20
• Device Lot Number: 1047253-013
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 01/10/2018; 01/10/2018
• Supplement Dates FDA Received: 05/31/2019; 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED-LOT: 1047076-037; AFX-BIFURCATED-LOT: 1047076-037
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR