MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-110/I16-30

Device Problems Material Puncture/Hole (1504); Stretched (1601); Material Integrity Problem (2978); Insufficient Information (3190)

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

Event Date 01/09/2019

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

The patient was initially implanted with a bifurcated stent graft and an infrarenal stent graft extension to treat an abdominal aortic aneurysm (aaa).Approximately 5.5 years post initial procedure, sac growth with no endoleak was identified by computerized tomography (ct) scan.An intervention is being discussed.The patient was reported in good condition and is being monitored.

Manufacturer Narrative

The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.At the completion of the clinical assessment, clinical was able to find substantial evidence to support the following events for this case; a type 3b endoleak of the of the bifurcated stent graft and a type 1a endoleak of the infrarenal extension with stent cage dilation on both devices and sac growth.The type 3b endoleak is mostly likely device related due to the use of strata material.The cause of the type 1a endoleak is unknown.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.No additional investigation of this reported event is planned however if additional information pertinent to the incident is obtained, a follow-up report will be submitted.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

Event Description

Additional information: a secondary procedure was completed.The physician elected to reline the original implanted devices with a non- endolgix (cook) stent to treat the reported event.At the completion of the clinical assessment, clinical was able to find substantial evidence to refute the claim of no endoleak rather there was a type 3b endoleak of the bifurcated stent graft and a type 1a endoleak of the infrarenal extension with additional findings of stent cage dilation of both the bifurcated stent graft and infrarenal extension.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8333236
• MDR Text Key: 135951027
• Report Number: 2031527-2019-00084
• 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,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 01/13/2019

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: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: BA25-110/I16-30
• Device Lot Number: 1101363-016
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2019
• Initial Date FDA Received: 02/12/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: INFRARENAL EXTENSION, LOT 1026594-005; INFRARENAL EXTENSION, LOT 1026594-005
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 64 YR