MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED STENT GRAFT

Model Number BA28-90/I20-30

Device Problems Fracture (1260); Leak/Splash (1354); Torn Material (3024)

Patient Problems Aneurysm (1708); Failure of Implant (1924); Pain (1994)

Event Date 11/09/2017

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 initially implanted with a bifurcated stent and a suprarenal aortic extension.It was reported the patient had sac growth and a stent fracture of the bifurcated stent.The fracture of the stent caused a tear in the fabric and a type 3b endoleak.The physician elected to implant a non-endologix cook device to resolve the issue.The current patient status is unknown.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

Based on the information received at the completion of the clinical evaluation, there were substantial reported evidence that supported the following case event.It was confirmed that patient had a stent fracture of the main body at bifurcation, a endoleak type 3b, and an aneurysm enlargement.A secondary procedure was done to resolve issue with a reline of a non-endologix graft.At 31 months post implant, patient was noted for pain.Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent graft integrity was related to the protruding stent strut of the main body near the aortic bifurcation.The most likely cause of the stent fracture could not be determined, however, the 72 degree angulation of the left common iliac artery (cautionary product use condition) likely contributed to the event.The final patient disposition was discharged post operative day two in stable condition.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; upgraded graft material (i.E.Duraply) and 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 iiib endoleak rate for afx manufactured and implanted before these corrective actions were put in place is trending at (b)(4)%.Since the corrective actions were implemented, the type iiib endoleak events reported for afx devices has been reduced to <0.2%.In addition, the review of manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.

• Brand Name: AFX
• Type of Device: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: victor arellano ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 7099138
• MDR Text Key: 94217930
• Report Number: 2031527-2017-00661
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)180310
• 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,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2018
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251915-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2015
• 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
• Treatment: VELA SUPRARENAL- 1252412-022
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR