MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-80/I16-40

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Material Puncture/Hole (1504); Product Quality Problem (1506); Stretched (1601); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

The devices involved in the event will not be returned for evaluation, they remain 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 implanted with an afx device on (b)(6) 2012.Recently during a routine exam the patient was presented with an (indeterminate) endoleak.The physician plans to schedule an angio (date unknown) to determine the source of the leak.As of the date of this report there have been no additional patient sequelae reported.The patient's status is unknown and no additional information was provided.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the reported event of type iiib of the bifurcated device.The complaint is most likely device-related due to use of strata material.The clinical assessment also determined that there was evidence to reasonably suggest a type iiia endoleak of the aortic components and stent cage dilation of both the bifurcated device (70%) and proximal extension (20%) occurred that were not included in the event as reported.The type iiia endoleak was likely related to the lack of overlap.Procedure-related harms for this complaint could not be determined.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.Outcomes attributed to adverse event - remove other serious.Device codes - remove 1068, 1354.Conclusion code - remove 11.

Event Description

Additional information received confirming that the physician elected to treat the patient by relining with a bifurcated afx2 and suprarenal afx devices on (b)(6) 2018.The potential iiib endoleak was confirmed resolved at the conclusion of the procedure, with no visible type ia endoleak.The patient reportedly tolerated the re-intervention well.In addition, the clinical assessment confirmed that a type iiia endoleak of the aortic components with stent cage dilation of the bifurcated and proximal extension devices were also present at the time of the event.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 7936456
• MDR Text Key: 122793344
• Report Number: 2031527-2018-00756
• 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: 09/06/2018

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: Health Professional
• Device Expiration Date: 10/30/2012
• Device Model Number: BA25-80/I16-40
• Device Lot Number: W11-5676-021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 03/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0006-2019; Z-0008-2019
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED STENT GRAFT-LOT: W11-6053-008; AFX-SUPRARENAL AORTIC EXTENSION: LOT: 1030002-019
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 87 YR