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

Model Number BA25-110/I20-30

Device Problems Hole In Material (1293); Leak/Splash (1354); Stretched (1601)

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

Event Date 10/16/2017

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, two suprarenal aortic extensions and a limb stent.A routine follow up showed aneurysm sac growth and a possible type 3b endoleak.On (b)(6) 2017 the patient had a secondary procedure completed.The physician elected to implant an additional bifurcated stent and a suprarenal aortic extension.The final patient status is unknown.To date there have been no additional adverse events reported for this patient.

Manufacturer Narrative

At the completion of the clinical evaluation and based on the information received, there was substantial evidence to support the following reported events: type 3b endoleak of the mb, aneurysm enlargement (+6mm/38m), and reline with mb and sr extension.The following additional events were also noted: (b)(6) 2017 (at 45 months post implant) and dilation of proximal main body stent by 36% (3.4 x 3.2cm).The most likely cause of the compromised stent graft integrity was related to the strata graft material with stent dilation of the proximal main body of 36%.Additionally, the oversized cuff for the main body diameter (off-label) likely contributed to the event.Associated clinical harms for this device failure included: type 3b endoleak, aneurysm enlargement, and a secondary endovascular procedure.The final patient disposition was unknown.To date there have been no additional adverse events reported for this patient.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; 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 (b)(6) 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 3b endoleak events reported for afx devices has been reduced to less than 0.2%.(b)(4).No codes removed.

• 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: 7031223
• MDR Text Key: 92020351
• Report Number: 2031527-2017-00600
• 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: 05/21/2018

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: 09/30/2014
• Device Model Number: BA25-110/I20-30
• Device Lot Number: 1101031-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/14/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2013
• 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: 81 YR