MAUDE Adverse Event Report: ENDOLOGIX INC. AFX; BIFURCATED

Model Number BA28-100/I16-40

Device Problems Failure To Adhere Or Bond (1031); Collapse (1099); Detachment Of Device Component (1104); Leak/Splash (1354); Torn Material (3024); Unintended Movement (3026)

Patient Problems Aneurysm (1708); Failure of Implant (1924)

Event Date 08/23/2016

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 a suprarenal aortic extension on (b)(6) 2014.A follow up computed tomography (ct) on (b)(6) 2016 showed a type 3a endoleak with component separation and aneurysm sac growth.The ct also identified the stent was kinked with a type 3b endoleak present.A subsequent endovascular procedure was completed on (b)(6) 2016.During the procedure the physician identified the material on the bifurcated stent was torn.The physician elected to reline the devices by implanting an ovation main body and two ovation limb extensions.The patient is stable.

Manufacturer Narrative

At the close of the complaint investigation, based on the patient data received, a clinical evaluation confirmed aneurysm sac growth, a type 3b endoleak and a type 3a endoleak with complete component separation and collapse of the main body stent.The root cause of the reported event is unknown.There is not enough information to determine the root cause of the reported event.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 not available for further evaluation.There have been no additional reported adverse events 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: 5989403
• MDR Text Key: 55988335
• Report Number: 2031527-2016-00457
• 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: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: BA28-100/I16-40
• Device Lot Number: 1053297-022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2013
• 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: SUPRARENAL AORTA UNI-ILIAC- (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR