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

Model Number A34-34/C80-O20

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

Patient Problems Failure of Implant (1924); Rupture (2208)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Based on the information received, clinical evaluation confirmed the reported type iiia endoleak with complete aortic component separation, type iiib endoleak of the cuff and rupture.Clinical evaluation was unable to confirm that the patient is to receive no treatment due to deteriorating condition.Additionally, clinical evaluation found a complete crown separation, and hyperdilation of the cuff (76%).The most likely cause of the mid aortic loss of seal was the stretched fabric of the cuff (76%) in combination with aortic remodeling.The most likely cause of the compromised stent graft integrity (stretched and breached) was the use of strata material.The most likely cause of the proximal loss of seal was the complete crown separation that was related to the use of strata material.It was reported the patient would receive no further treatment and was in deteriorating condition.There have been no reports of further negative patient sequelae.The devices remain implanted in the patient and will not be returned; therefore, device evaluation will not be completed.The review of manufacturing lot confirmed all devices met specifications prior to release.The afx bifurcated stent was previously reported to the fda under mfr# 2031527-2018-00175.

Event Description

Patient was initially implanted with an afx bifurcated and suprarenal device in 2012.On (b)(6) 2018, the patient presented emergently with an endoleak type iiia and type iiib.The decision was made not to re-intervene due to deteriorating patient condition.No additional event or patient information is available.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7524141
• MDR Text Key: 108600954
• Report Number: 2031527-2018-00468
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2018

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: No Information
• Device Expiration Date: 08/31/2015
• Device Model Number: A34-34/C80-O20
• Device Lot Number: 1025850-043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2012
• 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: 87 YR