MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA25-100/I16-40

Device Problems Collapse (1099); Hole In Material (1293); Leak/Splash (1354); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 01/27/2017

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.Devices remain implanted in the patient.

Event Description

The patient was initially implanted with a bifurcated stent and a suprarenal aortic extension.A follow up showed a type 3b endoleak with a large blush of contrast seen coming from the distal part of the main body graft.The physician elected to implant a non-endologix gore device to seal the endoleak.The secondary intervention was reported as successful.There have been no additional adverse events reported for this patient.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm a type 3b endoleak of the main body and the proximal extension.The evaluation additionally identified a stent collapse of the main body.The clinical evaluation identified the following potential contributing factors to the reported event; off label use due to patient anatomy, improper sizing of the proximal extension, stent collapse, and non compliance with follow up post operative surveillance.The review of the manufacturing lot 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 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 (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 <0.2%.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• MDR Report Key: 6419474
• MDR Text Key: 70407126
• Report Number: 2031527-2017-00117
• 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: 02/18/2017

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: 08/31/2015
• Device Model Number: BA25-100/I16-40
• Device Lot Number: 1047099-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2012
• 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: 72 YR