MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA28-90/I20-30

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Date 11/02/2016

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

It was reported the patient had an initial procedure on (b)(6) 2014 with a bifurcated stent, an infrarenal aortic extension, and two limb stent grafts.A follow up computed tomography (ct), showed a type 3a endoleak and component separation of the right iliac limb.The physician is planning a secondary procedure to repair the endoleak and component separation.The patient is in stable condition.

Manufacturer Narrative

At the completion of the complaint investigation, based on the information provided, the clinical evaluation was able to confirm a type 3a endoleak with component separation.Additionally there was evidence to reasonably support the following observations; a stent collapse due to severe angulation of the anatomy, occlusion of the left hypogastric snorkel and the use of a non-endologix stent in the distal iliac.The clinical evaluation also found evidence to reasonably suggest the following contributing factors to the reported event; off label use, patient anatomy and concomitant use of non-endologix products.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 of the reported event at this time.To date there have been no additional adverse events reported for this patient.

Event Description

Based on the clinical evaluation, it was confirmed the patient had a secondary endovascular procedure completed and the physician elected to implant a non-endologix stent 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: 6142231
• MDR Text Key: 61346749
• Report Number: 2031527-2016-00559
• 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: 11/02/2016

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: 07/31/2016
• Device Model Number: BA28-90/I20-30
• Device Lot Number: 1101191-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2014
• 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); LIMB STENT- (B)(4); LIMB STENT- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR