MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA28-90/I20-30

Device Problems Collapse (1099); Kinked (1339); Malposition of Device (2616)

Patient Problems Stenosis (2263); Claudication (2550)

Event Date 10/24/2016

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 was initially implanted with a bifurcated stent and an infrarenal aortic extension on (b)(6) 2016.Patient came in for follow up and had issues with their right and left leg, the physician diagnosed the patient with possible claudication.Computed tomography (ct) showed a potential narrowing in the limb of the bifurcated stent at the proximal common iliac artery.The physician elected to complete a secondary procedure and during the intervention the physician identified stenosis of the right common iliac artery (rcia).The physician completed a balloon angioplasty procedure to resolve the issue.The patient is in stable condition.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information received, the following reported events were confirmed; bilateral claudication, narrowing of the proximal graft, a kink which was over-crowding of struts caused by the small aortic-iliac junction.Additionally there was evidence to reasonably support the following observations; bilateral reduction of renal vascular due to juxtarenal position of the infrarenal cuff and intentional sacrifice of the right accessory renal artery.The clinical evaluation additionally found evidence to reasonably suggest the following contributing factors to the reported event; off label use, existing peripheral occlusive disease, patent anatomy, continued tobacco use, positioning of the cuff, and intentional sacrifice of the right accessory renal artery.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 evaluation.The root cause of the reported event is unknown.There is not enough information to determine the root cause at this time.There has been no additional adverse events reported for this patient.Correction: patient codes updated.Device codes updated.

• 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: 6123199
• MDR Text Key: 60742370
• Report Number: 2031527-2016-00551
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00818009012630
• UDI-Public: (01)00818009012630(17)180410
• 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: 10/24/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2018
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1251916-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• 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- 1252540-029
• Patient Outcome(s): Required Intervention