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

Model Number BA25-80/I16-55

Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Failure of Implant (1924)

Event Date 04/25/2018

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

Endologix became aware of a type ii endoleak (no alleged device deficiency) on (b)(6) 2018 as reported by physician (b)(6) at (b)(6) medicine.The date of event is (b)(6) 2018 based on the endoleak diagnosed during routine follow-up.The patient was originally implanted with an afx bifurcated stent graft, one (1) afx suprarenal aortic extension, and one (1) intuitrak limb extension on (b)(6) 2011 by physician (b)(6) at (b)(6) medicine.The physician was going to do an open repair to tie off the type ii endoleak, but after looking at the ct again on (b)(6) 2018, it was decided that an angiogram was needed to make sure there wasn't a strata issue.The angiogram showed a very slight blush of blood (indeterminate endoleak) and therefore, the physician decided it best to realign the entire graft and extend the left common iliac artery.Endologix became aware of the endoleak at an indeterminate origin on (b)(6) 2018 (reportable event).During re-intervention, the patient was treated by implanting an afx2 bifurcated stent graft, one (1) afx vela suprarenal, and one (1) ovation ix iliac limb on (b)(6) 2018 by the reporting physician.The patient tolerated the procedure well.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported event: the type ii endoleak (lumbar) complaint is confirmed.The complaint is most likely anatomy-related.Procedure-related harms for this complaint could not be determined based on the information shared with endologix to review.The final patient status was not reported.The clinical assessment also determined that there was evidence to reasonable suggest a type iiib endoleak with stent fracture and stent cage dilation of 24% occurred that was not included in the event as reported.These events were discovered on (b)(6) 2018 during review of the 77 month post implant ct scan.The manufacturing lot review confirmed all devices met specifications prior to release.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%.

• 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: 7651867
• MDR Text Key: 112788224
• Report Number: 2031527-2018-00573
• 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,Followup
• Report Date: 04/25/2018

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: Physician
• Device Expiration Date: 09/30/2012
• Device Model Number: BA25-80/I16-55
• Device Lot Number: W11-5094-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2011
• 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
• Treatment: AFX-SUPRARENAL AORTIC EXTENSION-LOT W11-4519-010; INTUITRAK-LIMB EXTENSION-LOT W11-2996-001
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR