MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA28-90/I16-30

Device Problems Partial Blockage (1065); Hole In Material (1293); Kinked (1339); Leak/Splash (1354); Migration or Expulsion of Device (1395); Occlusion Within Device (1423)

Patient Problems Failure of Implant (1924); Thrombus (2101)

Event Date 11/15/2016

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) 2012 with a bifurcated stent and two infrarenal aortic extensions.On (b)(6) 2016, a follow up computed tomography (ct) done on (b)(6) 2016 showed a potential type 3b endoleak.The physician elected to reline the initial stents with an ovation device.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.Additionally there was evidence to support the following observations; at implant an occlusion of the left iliac artery due to a kinked left iliac stent, the placement of two non-endologix stent to restore patency, proximal cuff migration, intra-stent mural thrombus, main body stent dilation, and insufficient distal stent overlap.The clinical evaluation additionally observed the following potential contributing factors; cuff migration, and intra-stent thrombus.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.The event devices remain implanted in the patient and were unavailable for further evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause at this time.There have been no additional adverse events reported for this patient.

• 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: 6216906
• MDR Text Key: 63687918
• Report Number: 2031527-2016-00600
• 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: 02/23/2017

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: 02/28/2013
• Device Model Number: BA28-90/I16-30
• Device Lot Number: 1032593-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2016
• Initial Date FDA Received: 12/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2012
• 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: AORTO UNI-ILIAC [INFRARENAL]- 1029457-010; AORTO UNI-ILIAC [INFRARENAL]- 1032596-018
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR