MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA28-100/I16-40

Device Problems Material Puncture/Hole (1504); Product Quality Problem (1506); Stretched (1601); Material Integrity Problem (2978)

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

Event Date 01/29/2019

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

The patient was initially treated for an abdominal aortic aneurysm (aaa) with the afx abdominal aortic aneurysm stent.Approximately 6.5 years post initial procedure, an aneurysm enlargement (6.4cm to 7.5cm) with a type iiib endoleak were detected during routine follow-up.The physician plans to reline with an endurant (non-endologix) device and re-intervention is scheduled.There have been no additional patient sequelae reported.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was unsubstantial evidence to support the reported event of aneurysm sac growth due to a lack of comparative imaging.However, there was substantial evidence to support the reported event of a type iiib endoleak of the bifurcated device.The event is most likely device-related due to the use of strata material.The clinical assessment also determined that there was evidence to reasonably suggest stent cage dilation of the bifurcated device (41%) occurred that was not included in the event as reported; the stent cage dilation was discovered during review of the 63-month post-implant ct scan.Procedure-related harms for this event could not be determined.The final patient status was reported in good condition post secondary endovascular procedure with a non-endologix stent.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 iiib endoleak.Endologix implemented the following corrective actions with the intent of reducing type iiib endoleak events; 1.Upgraded graft material (i.E.Duraply) and 2.Updates to the ifu and additional physician training.The change to duraply graft material and the ifu changes were put in place july 2014.

Event Description

Additional information received confirming that the physician elected to treat the patient by successfully relining with non-endologix devices on 15 feb 2019.The patient reportedly tolerated the procedure well.In addition, clinical assessment confirmed that stent cage dilation of the bifurcated device was also present at the time of the reported event.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8416378
• MDR Text Key: 138660225
• Report Number: 2031527-2019-00122
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1047132-022
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX-INFRARENAL AORTIC EXTENSION: 1026651-009; AFX-INFRARENAL AORTIC EXTENSION: 1026651-009
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR