MAUDE Adverse Event Report: ENDOLOGIX AFX; SUPRARENAL AORTIC EXTENSION

Model Number A25-25/C75-O20

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

Patient Problem Failure of Implant (1924)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to refute the reported indeterminate endoleak and rather, confirm a type iiib endoleak with stent cage dilation of both the cuff and main body, as well as a partial crown separation (type ia endoleak).This complaint is most likely device related.Anatomy related contributing factors included an approximately 90° ir angulation and an inadequate overlap at 80 months post implant.Procedure related harms include a persistent type ii endoleak and possible type ia endoleak persisting post endovascular intervention.The final patient status was reported to be doing well post-secondary intervention.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 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

The patient was initially treated with the afx abdominal aortic aneurysm stent.Approximately seven (7) years post initial procedure, an indeterminate endoleak was detected.The physician elected to treat the patient by implanting a suprarenal afx device on (b)(6) 2018.The patient was stable when leaving the operating room.As part of the clinical assessment for the event reported in mfr.Report # 2031527-2018-00710 (associated with the bifurcation device), the reported indeterminate endoleak was refuted and instead, a type iiib endoleak and stent cage dilation were confirmed with a type ia endoleak of the suprarenal device.Therefore, a second report was prompted (here) for the event associated with the suprarenal device.

• Brand Name: AFX
• Type of Device: SUPRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer (Section G): ENDOLOGIX; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 8056609
• MDR Text Key: 126881599
• Report Number: 2031527-2018-00852
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2018

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: 08/31/2012
• Device Model Number: A25-25/C75-O20
• Device Lot Number: W11-4585-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR