MAUDE Adverse Event Report: ENDOLOGIX AFX; BIFURCATED STENT GRAFT

Model Number BA25-60/I16-40

Device Problems Loss of or Failure to Bond (1068); Leak/Splash (1354); Material Puncture/Hole (1504); Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 08/30/2018

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 with the afx abdominal aortic aneurysm stent.Approximately seven (7) years post initial procedure, separation of the suprarenal extension from the main body with a type iiia endoleak were detected by angiogram.The physician elected to treat the patient by implanting an infrarenal afx device, and no devices were explanted.The patient tolerated the procedure well with no complications.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 substantial evidence to support the reported event of type iiia endoleak with component separation of the cuff and main body; this complaint is most likely anatomy related (aortic remodeling).The clinical assessment also determined that there was evidence to reasonably suggest type iiib endoleaks of both the cuff and main body, associated with stent cage dilation of both occurred that was not included in the event as reported.The type iiib endoleaks were discovered during review of the 81 month post implant ct scan.The use of strata material likely contributed to the type iiib endoleaks of both the cuff and main body.Procedure related harms for this complaint could not be determined.The final patient status was reported to be without additional sequelae post a successful secondary endovascular procedure.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 3a endoleak.The root causes have been identified as; 1.Patient anatomy including large aneurysms, aneurysm sac angulation, significant aortic neck angulation and lack of thrombus; 2.Patient conditions including disease progression or anatomical changes post implant; 3.Off label product use including patient anatomy, overlap length, oversizing between components, and placement of the devices within the anatomy of the patient.Endologix implemented the following corrective actions to reduce the type 3a endoleak events; 1.Sizing guidance and instructions were updated in the ifu and released on 17 jun 2015, 2.Field training was completed by 03 aug 2015.Since the corrective actions were implemented the type 3a events have been reduced significantly and are well within the acceptable range per our risk assessment.A root cause investigation was carried out for all afx complaints having an identified failure mode of a type 3b endoleak.Endologix implemented the following corrective actions with the intent of reducing type 3b 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.The type 3b endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at 2.5%.Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to <0.2%.

Event Description

Additional information received per clinical assessment confirming the presence of a type iiib endoleak with stent cage dilation of the main body 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: 7965574
• MDR Text Key: 123713907
• Report Number: 2031527-2018-00779
• 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
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

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: 06/30/2012
• Device Model Number: BA25-60/I16-40
• Device Lot Number: W11-3387-017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFX-SUPRARENAL AORTIC EXTENSION:W11-5064-021; AFX-SUPRARENAL AORTIC EXTENSION:W11-5064-021
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR