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

Catalog Number BA25-90/I20-30

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 06/10/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in this event will not be returned for evaluation and remain implanted in the patient.If additional information is obtained at a later time that is pertinent to this event, a follow-up report will then be submitted.

Event Description

Endologix became aware of a type iii endoleak and patient back pain on (b)(6) 2018 as reported by physician (b)(6) at (b)(6) hospital.During re-intervention, the patient was treated by implanting an afx2 bifurcated stent graft and one (1) afx vela suprarenal on (b)(6) 2018 by the reporting physician.The patient is doing well.No devices were explanted.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following event: the type iiib endoleak complaint is refuted, rather there is type iiia endoleak, loss of overlap.Device, user, procedure or anatomy relatedness of this complaint could not be determined based on the information shared with endologix to review.Procedure related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was reported to be in a stable condition post the secondary endovascular procedure.The manufacturing lot review confirmed all devices met specifications prior to release.Endologix continues to investigate this event and similar events to ensure the highest quality and patient safety.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; 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 3a endoleak events; 1.Sizing guidance and instructions were updated in the ifu and released on 17 jun 2015, 2.Field training was completed by 03 aug 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.

Event Description

Additional information received confirming that the date of event is 10 jun 2018, at which time a type iiib endoleak was diagnosed by ct scan.Also, the initial afx treatment details for procedure on 19 jun 2014 were confirmed.After clinical review, however, the type iiib endoleak was refuted and rather a type iiia endoleak was confirmed.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 7663599
• MDR Text Key: 113179246
• Report Number: 2031527-2018-00576
• 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: 06/10/2018

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: 04/30/2017
• Device Catalogue Number: BA25-90/I20-30
• Device Lot Number: 1257009-006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 06/10/2018
• Supplement Dates FDA Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-LIMB STENT GRAFT-LOT 1047172-016; AFX-VELA SUPRARENAL-LOT 1202762-024; AFX-LIMB STENT GRAFT-LOT 1047172-016; AFX-VELA SUPRARENAL-LOT 1202762-024
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR