MAUDE Adverse Event Report: ENDOLOGIX AFX; INFRARENAL AORTIC EXTENSION

Model Number A25-25/C75

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Product Quality Problem (1506); Material Integrity Problem (2978); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Rupture (2208)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

The explanted devices involved in this event have not be returned for evaluation.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

An afx bifurcated and suprarenal cuff were initially implanted.The four (4) year follow-up showed evidence of sac growth from the aaa, migration of the proximal cuff, and ruptured fabric of the cuff (type iiib endoleak).The patient was converted to open surgical repair on (b)(6) 2018 and the stent graft was explanted.As of the date of this report, the patient is reported as stable.

Manufacturer Narrative

A clinical evaluation of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging; requests were made and denied response was received.As such, event determination, off-label conditions, related patient harms, and patient disposition could not be independently assessed.In addition, endologix received one (1) afx a25-25/c75 infrarenal aortic extension that was explanted for evaluation.The evaluation results for the received device supported the reported type iiib endoleak.The infrarenal extension exhibits extensive damage to the graft uncharacteristic of explant procedure; while the stent cage of the aortic extension does not exhibit any damage or deformity, there is a tear in the graft which is likely evidence of the type iiib endoleak.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.Correction: device code - remove 1354 conclusion code - remove 11.

Event Description

This report is only for the proximal extension (suprarenal aortic extension).Reference mfr.Report 2031527-2019-00043 for the reported to the bifurcated stent graft.

• Brand Name: AFX
• Type of Device: INFRARENAL AORTIC EXTENSION
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8205452
• MDR Text Key: 131699488
• Report Number: 2031527-2018-00979
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

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: 08/31/2016
• Device Model Number: A25-25/C75
• Device Lot Number: 1046903-015
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/30/2018
• Supplement Dates Manufacturer Received: 11/30/2018
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0008-2019
• Patient Sequence Number: 1
• Treatment: AFX-BIFURCATED STENT GRAFT:1053204-026
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR