MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; AORTO UNI-ILIAC [INFRARENAL]

Model Number A28-28/C75

Device Problems Failure To Adhere Or Bond (1031); Partial Blockage (1065); Collapse (1099); Kinked (1339); Occlusion Within Device (1423); Malposition of Device (2616); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Occlusion (1984); Thrombus (2101); Stenosis (2263)

Event Date 11/12/2016

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.Devices remain implanted in the patient.

Event Description

Patient initially implanted with a bifurcated stent and two non-endologix stents on (b)(6) 2012.The non-endologix stents were used to exclude a left iliac artery aneurysm.During the initial procedure the bifurcated stent landed lower than expected and an infrarenal aortic extension was implanted to extend the seal zone.On (b)(6) 2016 a follow up computed tomography (ct) showed stent movement around an angled aorta causing a stent collapse an occlusion in the proximal neck of the aorta.The patient had limited flow in the distal stents and thrombus was noted in the non-endologix limb extension.The physician elected to implant two additional non-endologix stents to restore flow.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 the stent collapse, stent kink, and the occlusion within the aorta as well as the internal iliac stent.Additionally there was evidence to reasonably support the following observations; stent movement, aortic stenosis by malposition of suprarenal cuff, and partial thrombus formation within the cuff.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; off label use, patient anatomy, malposition of the device due to dislodgement likely caused during the removal of the delivery system, and continued tobacco use.The review of the manufacturing lot confirmed all devices met specifications prior to release.The event devices remain implanted in the patient and were not available 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.

• Brand Name: AFX
• Type of Device: AORTO UNI-ILIAC [INFRARENAL]
• Manufacturer (Section D): ENDOLOGIX INC.; 2 musick; irvine CA 92618
• Manufacturer Contact: tahereh sedighi ; 2 musick; irvine, CA 92618 ; 9495984671
• MDR Report Key: 6221014
• MDR Text Key: 63798396
• Report Number: 2031527-2017-00008
• 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: 12/08/2016

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: 08/31/2014
• Device Model Number: A28-28/C75
• Device Lot Number: W11-4521-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2012
• 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: BIFURCATED- (B)(4); NON-ENDOLOGIX STENT- LEFT EXTERNAL COMMON ILIAC; NON-ENDOLOGIX STENT- LEFT INTERNAL COMMON ILIAC
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR