MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-90/I20-30

Device Problems Misconnection (1399); Material Puncture/Hole (1504); Product Quality Problem (1506); Stretched (1601); Material Integrity Problem (2978); Insufficient Information (3190); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation.A follow-up report will be submitted upon completion of the investigation.

Event Description

The patient was initially implanted with a bifurcated stent graft and a vela suprarenal stent graft extension to treat an abdominal aortic aneurysm.Approximately five (5) years post initial implant the patient was found to have migration of the proximal cuff (unknown distance), possible type ia endoleak, type iiib endoleak, and potential separation.The physician has scheduled a secondary procedure which has yet to be completed.No further additional information or patient sequelae has been reported at this time.

Event Description

Additional information received confirming that the physician elected to treat the patient by relining with a bifurcated afx2 device on (b)(6) 2019.In addition, clinical assessment confirmed that dilation of the bifurcated device by 56% was also present at the time of the reported event.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: type iiia endoleak (aortic) and type iiib endoleak of the bifurcated device.The type iiib endoleak is most likely device-related due to the use of strata material.The reported migration and type ia endoleak of the proximal extension, however, is unconfirmed due to a lack of comparative imaging.The clinical assessment also determined that there was evidence to reasonably suggest that stent cage dilation (56%) of the bifurcated device occurred which was not included in the event as reported; the dilation was discovered during review of the 58-month post-implant ct scan.The procedure-related harms for this event and the device, user, procedure, or anatomy relatedness of the type iiia endoleak could not be determined.The final patient status was not reported.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.Device iteration is afx with strata.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8402197
• MDR Text Key: 138213420
• Report Number: 2031527-2019-00118
• 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: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• 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: BA25-90/I20-30
• Device Lot Number: 1100965-011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019
• Patient Sequence Number: 1
• Treatment: AFX VELA SUPRARENAL (LN 1203998-015)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 77 YR