MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA25-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 11/09/2016

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

It was reported the patient had an initial procedure on (b)(6) 2013 with a bifurcated stent, an infrarenal aortic extension, and a suprarenal aortic extension.A follow up computed tomography (ct) done on (b)(6) 2016 showed an unknown endoleak with possible sac growth.The physician plans to re-line the initial devices.A secondary intervention has not been scheduled, the patient remains in stable condition.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the clinical evaluation was able to confirm the reported aneurysm sac growth.The reported unknown endoleak was determined to be a type 3a endoleak.Additionally there was evidence to reasonably support the following observations; a type 2 endoleak, a near total stent cage collapse, and renal ischemia.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; off label use, patient anatomy, multiple large lumbar arteries, and renal ischemia potentially from planned covering of the renal arteries.The manufacturing evaluation did not reveal any issues or deviations that would explain the reported event.The manufacturing lot evaluation confirmed all devices met specifications prior to release.Devices remain implanted in the patient and were not available for further investigation.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event.There have been no additional adverse events reported for this patient.

Event Description

Additional information received, the patient had a secondary intervention on (b)(6) 2016.The physician elected to implant an additional bifurcated stent and an infrarenal aortic extension to seal the endoleak.

• Brand Name: AFX
• Type of Device: BIFURCATED
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6175751
• MDR Text Key: 62421618
• Report Number: 2031527-2016-00582
• 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: 02/07/2017

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: 1047099-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2017
• 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
• Treatment: INFRARENAL AORTO UNI-ILIAC- (B)(4); SUPRARENAL AORTA UNI-ILIAC- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR